Prescription drug · ANDA
Zolpidem Tartrate NDC 72162-2441
Zolpidem tartrate 12.5 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2441-1 | 72162244101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-1)Marketed from Jan 15, 2025 | |
| 72162-2441-3 | 72162244103 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-3)Marketed from Jan 15, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Bryant Ranch Prepack
- 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 Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 72162-2441_5648ce94-ab6e-40c5-a40e-fa90d79e3c89SPL ID 5648ce94-ab6e-40c5-a40e-fa90d79e3c89SPL set ID 8425be72-2bbe-4090-b00e-610f1a1646b1RxCUI 854880UNII WY6W63843K
- Pharmacologic class
- gamma-Aminobutyric Acid A Receptor Positive Modulator
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
N472162244101followed by a unit qualifier and the quantityPackage 72162-2441-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Zolpidem tartrate extended-release tablets, USP are indicated for the short-term 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 short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenan…
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 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 | Sun Pharmaceutical Industries, Inc. | 47335-308 |
| 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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-254 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8376 |