Ambien CR
- Product NDC
- 21695-319
- 11-digit product format
- 216950319
- Labeler code
- 21695
- Product ID
- 21695-319_e242ca9c-63bc-44a3-abcf-99632e7703fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- NDA021774
- Marketing category
- NDA
- Marketing start
- 2009-06-30
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 6 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 21695-319-30 | Ambien CR | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| zolpidem tartrate | ACTIVE INGREDIENT | WY6W63843K | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| zolpidem | ACTIVE MOIETY | 7K383OQI23 | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| potassium bitartrate | INACTIVE INGREDIENT | NPT6P8P3UU | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-319 | AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [REBEL DISTRIBUTORS CORP.] | 1 | Legacy NDC, 1 package rows | 20100629_968b5154-3c38-4f20-bbeb-495bcb91cc2b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-319-30 | 21695031930 | 30 in 1 BOTTLE | Historical |