Makena
- Product NDC
- 64011-301
- 11-digit product format
- 640110301
- Labeler code
- 64011
- Product ID
- 64011-301_2586f54d-3cef-46fe-b5e8-1dc9a9861ee3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyprogesterone caproate
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- AMAG Pharmaceuticals, Inc.
- Application
- NDA021945
- Marketing category
- NDA
- Marketing start
- 2018-02-14
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64011-301-03 | 64011030103 | 1 SYRINGE in 1 CARTON (64011-301-03) > 1.1 mL in 1 SYRINGE | 1 syringe | 2018-02-14 | 0000-00-00 | No | No | Current |