Provepharm Inc.
NDC labeler code: 81284
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
- Piperacillin and tazobactamZosyn in Galaxy Containers, Zosyn · 5 products
- PhenylephrineBiorphen, Immphentiv · 3 products
- Tranexamic acidCyklokapron · 2 products
- Dihydroergotamine mesylateBrekiya, Trudhesa, Atzumi · 1 product
- Indigotindisulfonate sodiumBludigo · 1 product
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.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 8, 2022 | NDA216264 | Indigotindisulfonate sodium BLUDIGO | Provepharm Sas |
| July 17, 2020 | ANDA211081 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Milla Pharms |
| January 7, 2020 | ANDA212046 | Dihydroergotamine mesylate DIHYDROERGOTAMINE MESYLATE | Milla Pharms |
| July 17, 2019 | ANDA212676 | Tranexamic acid TRANEXAMIC ACID | Milla Pharms |
| January 13, 2017 | ANDA207847 | Piperacillin and tazobactam PIPERACILLIN AND TAZOBACTAM | Milla Pharms |
| January 13, 2017 | ANDA207848 | Piperacillin and tazobactam PIPERACILLIN AND TAZOBACTAM | Milla Pharms |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
November 22, 2024 · Class II · Ongoing · D-0150-2025 · Dihydroergotamine mesylate
Discoloration
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
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