Ambien
- Product NDC
- 55289-205
- 11-digit product format
- 552890205
- Labeler code
- 55289
- Product ID
- 55289-205_d92fc1df-bbee-592a-e053-2a95a90a6951
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- NDA021774
- Marketing category
- NDA
- Marketing start
- 2005-09-19
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- DEA schedule
- CIV
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-205-30 | 55289020530 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-205-30) | 2010-10-13 | 0000-00-00 | No | No | Current |