AMBIEN
- Product NDC
- 61919-803
- 11-digit product format
- 619190803
- Labeler code
- 61919
- Product ID
- 61919-803_9c5941d2-59d4-a016-e053-2a95a90a4fea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZOLPIDEM TARTRATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA076410
- Marketing category
- ANDA
- Marketing start
- 2016-01-28
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61919-803-30 | AMBIEN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-803 | AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [DIRECT RX] | 2 | Legacy NDC, 1 package rows | 20200129_33d47ab6-9b84-58b0-e054-00144ff8d46c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61919-803-30 | 61919080330 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-803-30) | 2016-01-28 | 0000-00-00 | No | No | Current |