Prescription drug · ANDA
Zolpidem Tartrate NDC 71610-254
Zolpidem tartrate 12.5 mg/1 · Tablet, Film coated, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-254-30 | 71610025430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-254-30)Marketed from Mar 22, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zolpidem Tartrate
- Generic name (nonproprietary)
- zolpidem tartrate
- Active ingredients
- Zolpidem tartrate — 12.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204170
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)Pyridines (Chemical structure)
- Identifiers
- Product ID 71610-254_3c965d39-7948-4e44-bd0c-62edb4501751SPL ID 3c965d39-7948-4e44-bd0c-62edb4501751SPL set ID ebd6c66b-b230-48d7-b38f-d610b6cb2b6cRxCUI 854880UNII WY6W63843K
- Pharmacologic class
- gamma-Aminobutyric Acid-ergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471610025430followed by a unit qualifier and the quantityPackage 71610-0254-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Zolpidem tartrate extended-release tablets, USP are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies ( 14 )] . Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1)…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204170
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 72162-2441 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-308 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-307 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1468 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-913 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8376 |