Makena
- Product NDC
- 64011-247
- 11-digit product format
- 640110247
- Labeler code
- 64011
- Product ID
- 64011-247_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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64011-247-02 | 64011024702 | 4 CARTON in 1 TRAY (64011-247-02) > 1 VIAL, GLASS in 1 CARTON > 1 mL in 1 VIAL, GLASS | 4 carton | 2011-02-03 | 0000-00-00 | No | No | Current |