Zolpidem Tartrate
- Product NDC
- 71610-564
- 11-digit product format
- 716100564
- Labeler code
- 71610
- Product ID
- 71610-564_64f6704f-5cba-4299-b85f-d95bb633f29d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078148
- Marketing category
- ANDA
- Marketing start
- 2010-12-03
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 13 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-564 | ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20210703_2977f646-8a5a-4e7b-94e1-0b0c0c5478ba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-564-30 | 71610056430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-564-30) | 2021-06-02 | 0000-00-00 | No | No | Current |