Prescription drug · ANDA
Zolpidem Tartrate NDC 0904-6082
Zolpidem tartrate 5 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6082-61 | 00904608261 | 100 BLISTER PACK in 1 CARTON (0904-6082-61) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 5, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077903
- 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 0904-6082_ef269a36-6712-4563-9436-a6b4b53f0d5cSPL ID ef269a36-6712-4563-9436-a6b4b53f0d5c
- 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
N400904608261followed by a unit qualifier and the quantityPackage 00904-6082-61. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 077903
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 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc | 68071-1887 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-233 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5093 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3549 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5120 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-263 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4598 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2232 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1023 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-1022 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-064 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0301 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | DirectRX | 61919-663 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Direct_Rx | 61919-751 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-1398 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9126 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0322 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9127 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0059 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-970 |
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