Hydroxyprogesterone Caproate
- Product NDC
- 67457-886
- 11-digit product format
- 674570886
- Labeler code
- 67457
- Product ID
- 67457-886_de125640-ce76-45dd-a7ed-de187b746a90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyprogesterone Caproate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Mylan Institutional LLC
- Application
- ANDA200271
- Marketing category
- ANDA
- Marketing start
- 2017-09-22
- Marketing end
- 0000-00-00
- Substance
- HYDROXYPROGESTERONE CAPROATE
- Active strength
- 250 mg/mL
- Pharmacologic classes
- Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 67457-886 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 67457-886 | 67457-886-05 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A200271-001 | HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION / INTRAMUSCULAR | | | 2015-08-24 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-886-05 | 67457088605 | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-886-05) > 5 mL in 1 VIAL, MULTI-DOSE | 2017-09-22 | 0000-00-00 | No | No | Current |