Prescription drug · ANDA
Zolpidem Tartrate NDC 80425-0059
Zolpidem tartrate 10 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0059-1 | 80425005901 | 30 TABLET in 1 BOTTLE (80425-0059-1)Marketed from Sep 5, 2007 | |
| 80425-0059-2 | 80425005902 | 60 TABLET in 1 BOTTLE (80425-0059-2)Marketed from Apr 24, 2023 | |
| 80425-0059-3 | 80425005903 | 90 TABLET in 1 BOTTLE (80425-0059-3)Marketed from Apr 24, 2023 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 80425-0059_2a98d9c1-b770-40b1-e063-6294a90a20e4SPL ID 2a98d9c1-b770-40b1-e063-6294a90a20e4SPL set ID af87ae17-a3c5-a3a5-e053-2a95a90aa4b0RxCUI 854873UNII 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
N480425005901followed by a unit qualifier and the quantityPackage 80425-0059-01. 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)
1. Indications and Usage 1 INDICATIONS AND USAGE Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see CLINICAL STUDIES (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Excerpt only. Read the full label for complete information.
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 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6082 |
| 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 | Calvin Scott & Co., Inc. | 17224-970 |
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