Makena
- Product NDC
- 64011-243
- Requested package NDC
- 64011-243-01
- 11-digit product format
- 640110243
- Labeler code
- 64011
- Product ID
- 64011-243_2586f54d-3cef-46fe-b5e8-1dc9a9861ee3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyprogesterone caproate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- AMAG Pharmaceuticals, Inc.
- Application
- NDA021945
- Marketing category
- NDA
- Marketing start
- 2011-02-03
- 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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 64011-243 | 64011-243-01 | D | Discontinued by firm | 2026-07-31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64011-243-01 | ML - Milliliter | 64011-243 | 03c20a4e-36e2-494a-922f-298903bd3074 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDROXYPROGESTERONE CAPROATE | ACTIVE INGREDIENT | 276F2O42F5 | MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.] | 8 | |
| HYDROXYPROGESTERONE | ACTIVE MOIETY | 21807M87J2 | MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.] | 8 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.] | 8 | |
| BENZYL BENZOATE | INACTIVE INGREDIENT | N863NB338G | MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.] | 8 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.] | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64011-243-01 | 64011024301 | 1 VIAL, GLASS in 1 CARTON (64011-243-01) > 5 mL in 1 VIAL, GLASS | 2011-02-03 | 0000-00-00 | No | No | Current |