Prescription drug · ANDA
Zolpidem (Zolpidem tartrate) NDC 80425-0430
Zolpidem tartrate 5 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0430-1 | 8042504300180425043001 | 30 TABLET in 1 BOTTLE (80425-0430-1)Marketed from Aug 13, 2024 | |
| 80425-0430-2 | 8042504300280425043002 | 60 TABLET in 1 BOTTLE (80425-0430-2)Marketed from Aug 13, 2024 | |
| 80425-0430-3 | 8042504300380425043003 | 90 TABLET in 1 BOTTLE (80425-0430-3)Marketed from Aug 13, 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
- Generic name (nonproprietary)
- zolpidem tartrate
- Active ingredients
- Zolpidem tartrate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077214
- 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 80425-0430_1fa85237-6f77-fa21-e063-6294a90a1d75SPL ID 1fa85237-6f77-fa21-e063-6294a90a1d75SPL set ID 1fa86b79-8809-35f4-e063-6394a90a4377RxCUI 854876UNII 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
N480425043001followed by a unit qualifier and the quantityPackage 80425-0430-01. 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 Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has 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 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 80425-0430
- What is NDC 80425-0430?
- 80425-0430 is the product NDC for Zolpidem (zolpidem tartrate), Zolpidem tartrate 5 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zolpidem (Zolpidem Tartrate).
- What is the active ingredient?
- Zolpidem tartrate.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zolpidem?
- 15 other product NDCs are listed under this name. See all Zolpidem NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zolpidem products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1170 | 63629-1170-01 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8998 | 63629-8998-0163629-8998-0263629-8998-03 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8999 | 63629-8999-0163629-8999-0263629-8999-03 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9613 | 63629-9613-01 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9614 | 63629-9614-01 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | ACI Healthcare USA, Inc | 71093-155 | 71093-0155-0471093-0155-06 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | ACI Healthcare USA, Inc | 71093-156 | 71093-0156-0471093-0156-06 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Proficient Rx LP | 71205-691 | 71205-0691-3071205-0691-6071205-0691-90 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2303 | 71335-2303-01 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9684 | 71335-9684-0071335-9684-0171335-9684-02+7 more |
Other NDCs under ANDA 077214
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 |
|---|---|---|---|---|
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1170 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8998 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8999 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9613 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9614 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | ACI Healthcare USA, Inc | 71093-155 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | ACI Healthcare USA, Inc | 71093-156 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Proficient Rx LP | 71205-691 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2303 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9684 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-670 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-847 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-848 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1982 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1983 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-941 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-942 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-904 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-915 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | The ACME Laboratories Ltd. | 72722-103 |
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