Prescription drug · ANDA
Zolpidem Tartrate NDC 68788-8654
Zolpidem tartrate 6.25 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8654-3 | 68788865403 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-3)Marketed from May 9, 2024 | |
| 68788-8654-6 | 68788865406 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-6)Marketed from May 9, 2024 | |
| 68788-8654-9 | 68788865409 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8654-9)Marketed from May 9, 2024 |
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 — 6.25 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078970
- 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 68788-8654_542b2687-71b1-4b46-bf3c-c3f28bfaa724SPL ID 542b2687-71b1-4b46-bf3c-c3f28bfaa724SPL set ID 76ff87e4-3aa2-439d-8436-d9e6affb33c8RxCUI 854894UNII 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
N468788865403followed by a unit qualifier and the quantityPackage 68788-8654-03. 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 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 extended-release tablet, 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078970
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, Extended releaseOral | Bryant Ranch Prepack | 71335-2085 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-318 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-319 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-839 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc.. | 68788-7422 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-779 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-780 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-819 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2354 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 72189-230 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1180 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2764 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-730 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-286 |