Zolpidem tartrate sublingual
- Product NDC
- 49884-898
- 11-digit product format
- 498840898
- Labeler code
- 49884
- Product ID
- 49884-898_8b73c0fb-c016-45f2-ab42-78d4225b6cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem tartrate sublingual
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA204229
- Marketing category
- ANDA
- Marketing start
- 2017-09-11
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 1.75 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolpidem tartrate sublingual
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 1.75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 1232194, 1232202 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-898-11 | Zolpidem tartrate sublingual | 30 in 1 CARTON | TABLET | 30 | | 23 |
| 49884-898-52 | Zolpidem tartrate sublingual | 1 in 1 POUCH | TABLET | 1 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-898 | ZOLPIDEM TARTRATE SUBLINGUAL TABLET [ENDO USA, INC.] | 22 | Current NDC, Legacy NDC, 2 package rows | 20240713_44b34e58-114b-4774-9fab-4b188dfe0228.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-898-11 | 49884089811 | 30 POUCH in 1 CARTON (49884-898-11) / 1 TABLET in 1 POUCH (49884-898-52) | 30 pouch | 2017-09-11 | 0000-00-00 | No | No | Current |
| 49884-898-52 | 49884089852 | 1 in 1 POUCH | | | | | | Historical |