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Drug company (FDA labeler)

Civica, Inc.

NDC labeler code: 72572

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

102Products (NDC)

Prescription medicines

Show the other 19 medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
ApprovedApplicationMedicineSponsor
March 13, 2025NDA215425 Epinephrine
EPINEPHRINE
Fresenius Kabi USA
June 21, 2024ANDA218314 Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous
SODIUM PHOSPHATES
Am Regent
May 16, 2024ANDA212580 Azacitidine
AZACITIDINE
Msn Labs Pvt Ltd
February 27, 2024ANDA216042 Sodium bicarbonate
SODIUM BICARBONATE
Long Grove Pharms
January 30, 2023NDA217415 Daptomycin
DAPTOMYCIN
Hikma
October 7, 2022NDA216109 Cefazolin
CEFAZOLIN SODIUM
Hikma
September 26, 2022ANDA203125 Methylprednisolone
METHYLPREDNISOLONE SODIUM SUCCINATE
Hikma
August 18, 2022ANDA216154 Meropenem
MEROPENEM
Brooks Steriscience
July 28, 2021BLA761201 Insulin glargine
SEMGLEE
Mylan Pharms Inc
September 16, 2020ANDA205576 Propofol
PROPOFOL
Innopharma
August 3, 2020NDA212593 Vasopressin
VASOPRESSIN
Am Regent
June 1, 2020ANDA211966 Magnesium sulfate heptahydrate
MAGNESIUM SULFATE, MAGNESIUM SULFATE IN PLASTIC CONTAINER
Baxter Hlthcare Corp
April 9, 2020ANDA212808 Ropivacaine hydrochloride
ROPIVACAINE HYDROCHLORIDE
Caplin
December 4, 2019ANDA212791 Dexmedetomidine
DEXMEDETOMIDINE HYDROCHLORIDE
Wilshire Pharms Inc
November 26, 2019NDA212832 Potassium phosphates
POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE
Fresenius Kabi USA
March 18, 2019ANDA210363 Diazepam
DIAZEPAM
Regcon Holdings
October 18, 2018ANDA211359 Norepinephrine bitartrate
NOREPINEPHRINE BITARTRATE
Sandoz
September 28, 2018ANDA078990 Enoxaparin sodium
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Gland
October 20, 2017NDA209949 Daptomycin
DAPTOMYCIN
Hikma
September 15, 2017ANDA209900 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Baxter Hlthcare Corp
August 23, 2017ANDA209784 Ephedrine sulfate
EPHEDRINE SULFATE
Sandoz
July 27, 2017ANDA209088 Calcium chloride
CALCIUM CHLORIDE 10%
Am Regent
June 30, 2017NDA209463 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Hikma
February 28, 2017ANDA204679 Rocuronium bromide
ROCURONIUM BROMIDE
West Ward Pharm Corp
November 1, 2016ANDA204216 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Gland
Show the other 49 applications
ApprovedApplicationMedicineSponsor
June 15, 2016ANDA206005 Daptomycin
DAPTOMYCIN
Xellia Pharms Aps
April 19, 2016ANDA206086 Meropenem
MEROPENEM
Savior Lifetec Corp
March 22, 2016ANDA204052 Acetaminophen
ACETAMINOPHEN
Sandoz
February 25, 2016ANDA202354 Etomidate
ETOMIDATE
Hikma
December 28, 2015ANDA207042 Neostigmine methylsulfate
NEOSTIGMINE METHYLSULFATE
Hikma
September 2, 2015ANDA206369 Water
STERILE WATER FOR INJECTION
Hikma
May 21, 2015ANDA205758 Morphine sulfate
MORPHINE SULFATE
Hikma
August 15, 2014ANDA065458 Piperacillin and tazobactam
PIPERACILLIN AND TAZOBACTAM
Onesource Specialty
April 9, 2014ANDA201025 Ampicillin
AMPICILLIN SODIUM
Onesource Specialty
April 7, 2014ANDA201024 Ampicillin sodium and sulbactam sodium
AMPICILLIN AND SULBACTAM
Onesource Specialty
January 27, 2014ANDA202747 Furosemide
FUROSEMIDE
Baxter Hlthcare Corp
December 20, 2012NDA203826 Phenylephrine
IMMPHENTIV, PHENYLEPHRINE HYDROCHLORIDE
Hikma
May 31, 2012ANDA201692 Clindamycin
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
Sandoz Inc
May 30, 2012ANDA090862 Voriconazole
VORICONAZOLE
Sandoz Inc
October 13, 2011ANDA090981 Levetiracetam
LEVETIRACETAM
Hikma Farmaceutica
September 21, 2011ANDA090963 Glycopyrrolate
GLYCOPYRROLATE
Hikma Farmaceutica
May 31, 2011ANDA065523 Piperacillin and tazobactam
PIPERACILLIN AND TAZOBACTAM
Acs Dobfar Spa
November 17, 2009ANDA090534 Nicardipine
NICARDIPINE HYDROCHLORIDE
Am Regent
May 21, 2008ANDA040745 Cyclophosphamide
CYCLOPHOSPHAMIDE
Baxter Hlthcare
April 30, 2008ANDA079196 Bumetanide
BUMETANIDE
West-Ward Pharms Int
January 10, 2008ANDA065342 Ceftriaxone sodium
CEFTRIAXONE
Hikma Farmaceutica
May 30, 2007ANDA077761 Metoprolol
METOPROLOL TARTRATE
Hikma Farmaceutica
December 26, 2006ANDA077541 Ondansetron
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Hikma
October 18, 2004ANDA065143 Cefazolin
CEFAZOLIN SODIUM
Hikma Farmaceutica
September 18, 2001ANDA065047 Cefazolin
CEFAZOLIN SODIUM
Hikma Farmaceutica
December 15, 2000NDA020873 Bivalirudin
ANGIOMAX
Sandoz
June 20, 2000ANDA075243 Midazolam
MIDAZOLAM HYDROCHLORIDE
Hikma
May 28, 1999ANDA075303 Labetalol
LABETALOL HYDROCHLORIDE
Hikma
June 30, 1997ANDA040136 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE
Am Regent
March 22, 1996ANDA074524 Ketamine hydrochloride
KETAMINE HYDROCHLORIDE
Hikma
January 27, 1995ANDA074441 Bumetanide
BUMETANIDE
Sagent
July 12, 1993ANDA062797 Ampicillin
AMPICILLIN SODIUM
Acs Dobfar Spa
December 21, 1990ANDA063076 Vancomycin
VANCOMYCIN HYDROCHLORIDE
Hospira
August 29, 1989ANDA089903 Prochlorperazine
PROCHLORPERAZINE EDISYLATE
Hikma
August 4, 1988ANDA062912 Vancomycin
VANCOMYCIN HYDROCHLORIDE
Hospira
December 1, 1987ANDA071192 Aminocaproic acid
AMINOCAPROIC ACID
Luitpold
May 12, 1987ANDA062719 Ampicillin
AMPICILLIN SODIUM
Acs Dobfar Spa
July 23, 1986ANDA089335 Glycopyrrolate
GLYCOPYRROLATE
Am Regent
December 16, 1985ANDA070313 Diazepam
DIAZEPAM
Hikma
October 22, 1985ANDA070299 Naloxone hydrochloride
NALOXONE
Hikma
July 11, 1984NDA019101 Fentanyl
FENTANYL CITRATE
Hikma
September 7, 1982ANDA087702 Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE
Hikma
December 24, 1981NDA018657 Metronidazole
FLAGYL I.V. RTU IN PLASTIC CONTAINER
Baxter Hlthcare
May 19, 1981NDA018267 Furosemide
FUROSEMIDE
Hikma
July 25, 1980NDA018140 Lorazepam
ATIVAN
Hikma
July 15, 1975ANDA084282 Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE
Hikma
June 16, 1975ANDA084625 Lidocaine
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Hikma
March 22, 1972NDA017037 Heparin sodium
HEPARIN SODIUM
Hikma
August 20, 1952NDA008453 Succinylcholine
ANECTINE
Sandoz

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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