Drug company (FDA labeler)
Caplin Steriles Limited
NDC labeler code: 65145
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.
Prescription medicines
- Ropivacaine hydrochlorideNaropin · 6 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 6 products
- PhenylephrineBiorphen, Immphentiv · 6 products
- Milrinone lactateMilrinone Lactate in Dextrose · 5 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 4 products
- OfloxacinOcuflox · 4 products
- TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 3 products
- Haloperidol decanoate3 products
- LevetiracetamKeppra, Spritam, Keppra XR · 3 products
- Brimonidine tartrate and timolol maleateCombigan · 3 products
- Sodium phosphatesSodium Phosphates · 3 products
- Cisatracurium besylate3 products
- Calcium gluconate3 products
- Potassium phosphate, monobasic potassium phosphate, dibasic injection,Potassium Phosphates · 3 products
- Verapamil hydrochloride2 products
- Desmopressin acetateDdavp, Stimate, Desmoda · 2 products
- Procainamide hydrochloride2 products
- NicardipineCardene IV · 2 products
- LabetalolLabetalol HCL in Dextrose · 2 products
- Neostigmine methylsulfateBloxiverz · 2 products
- EtomidateAmidate · 2 products
- Methylprednisolone acetateDepo-Medrol · 2 products
- Rocuronium bromide2 products
- Sodium nitroprussideNipride Rtu · 1 product
- ProchlorperazineCompro · 1 product
- Thiamine hydrochloride1 product
- LinezolidZyvox · 1 product
- Tranexamic acidCyklokapron · 1 product
- Norepinephrine bitartrateLevophed · 1 product
- GatifloxacinZymaxid · 1 product
- DifluprednateDifluprednate Ophthalmic Emulsion, Durezol · 1 product
- Foscarnet sodiumFoscavir · 1 product
- Carboprost tromethamineHemabate · 1 product
- SumatriptanImitrex, Tosymra, Zembrace Symtouch · 1 product
- Argatroban1 product
- Acetaminophen1 product
- Ephedrine sulfateEmerphed Pfs, Akovaz, Emerphed · 1 product
- PhytonadioneVitamin K1 · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 13, 2026 | ANDA220068 | Foscarnet sodium FOSCARNET SODIUM | Caplin |
| May 4, 2026 | ANDA218840 | Calcium gluconate CALCIUM GLUCONATE | Caplin |
| March 12, 2026 | ANDA220373 | Potassium phosphate, monobasic potassium phosphate, dibasic injection, POTASSIUM PHOSPHATES | Caplin |
| February 27, 2026 | ANDA219981 | Desmopressin acetate DESMOPRESSIN ACETATE | Caplin |
| February 23, 2026 | ANDA220683 | Sodium phosphates SODIUM PHOSPHATES | Caplin |
| January 26, 2026 | ANDA220556 | Methylprednisolone acetate METHYLPREDNISOLONE ACETATE | Caplin |
| December 8, 2025 | ANDA219558 | Linezolid LINEZOLID | Caplin |
| December 5, 2025 | ANDA219096 | Acetaminophen ACETAMINOPHEN | Caplin |
| October 22, 2025 | ANDA220243 | Nicardipine NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | Caplin |
| September 2, 2025 | ANDA219170 | Milrinone lactate MILRINONE LACTATE IN DEXTROSE 5% | Caplin |
| May 13, 2025 | ANDA219168 | Haloperidol decanoate HALOPERIDOL DECANOATE | Caplin |
| April 17, 2025 | ANDA219212 | Phytonadione PHYTONADIONE | Caplin |
| February 25, 2025 | ANDA219093 | Brimonidine tartrate and timolol maleate BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | Caplin |
| February 4, 2025 | ANDA218674 | Procainamide hydrochloride PROCAINAMIDE HYDROCHLORIDE | Caplin |
| January 16, 2025 | ANDA219562 | Levetiracetam LEVETIRACETAM IN SODIUM CHLORIDE | Caplin |
| December 13, 2024 | ANDA219441 | Difluprednate DIFLUPREDNATE | Caplin |
| August 7, 2024 | ANDA218460 | Timolol TIMOLOL MALEATE | Caplin |
| July 18, 2024 | ANDA219050 | Ephedrine sulfate EPHEDRINE SULFATE | Caplin |
| May 23, 2024 | ANDA215183 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Caplin |
| April 12, 2024 | ANDA217904 | Ofloxacin OFLOXACIN | Caplin |
| March 26, 2024 | ANDA218204 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Caplin |
| January 5, 2024 | ANDA217903 | Ofloxacin OFLOXACIN | Caplin |
| September 15, 2023 | ANDA217575 | Norepinephrine bitartrate NOREPINEPHRINE BITARTRATE | Caplin |
| June 9, 2023 | ANDA217725 | Cisatracurium besylate CISATRACURIUM BESYLATE | Caplin |
| May 10, 2023 | ANDA217789 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Caplin |
Show the other 17 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 6, 2023 | ANDA215692 | Thiamine hydrochloride THIAMINE HYDROCHLORIDE | Caplin |
| March 2, 2023 | ANDA216234 | Rocuronium bromide ROCURONIUM BROMIDE | Caplin |
| February 13, 2023 | ANDA216882 | Carboprost tromethamine CARBOPROST TROMETHAMINE | Caplin |
| November 3, 2021 | ANDA213542 | Gatifloxacin GATIFLOXACIN | Caplin |
| September 7, 2021 | ANDA214533 | Labetalol LABETALOL HYDROCHLORIDE | Caplin |
| July 13, 2021 | ANDA213998 | Sumatriptan SUMATRIPTAN SUCCINATE | Caplin |
| April 22, 2021 | ANDA214379 | Prochlorperazine PROCHLORPERAZINE EDISYLATE | Caplin |
| April 20, 2021 | ANDA213074 | Neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE | Caplin |
| April 16, 2021 | ANDA214380 | Milrinone lactate MILRINONE LACTATE | Caplin |
| January 21, 2021 | ANDA214235 | Argatroban ARGATROBAN | Caplin |
| December 18, 2020 | ANDA215028 | Etomidate ETOMIDATE | Caplin |
| June 11, 2020 | ANDA213318 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Caplin |
| April 9, 2020 | ANDA212808 | Ropivacaine hydrochloride ROPIVACAINE HYDROCHLORIDE | Caplin |
| March 25, 2020 | ANDA213232 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Caplin |
| November 29, 2019 | ANDA211016 | Sodium nitroprusside SODIUM NITROPRUSSIDE | Caplin |
| July 17, 2019 | ANDA212360 | Tranexamic acid TRANEXAMIC ACID | Caplin |
| March 20, 2019 | ANDA211705 | Glycopyrrolate GLYCOPYRROLATE | Caplin |
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.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026