Prescription drug · ANDA
Zolpidem Tartrate NDC 71610-904
Zolpidem tartrate 5 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-904-10 | 71610090410 | 10 TABLET, FILM COATED in 1 BOTTLE (71610-904-10)Marketed from May 6, 2025 | |
| 71610-904-14 | 71610090414 | 14 TABLET, FILM COATED in 1 BOTTLE (71610-904-14)Marketed from May 6, 2025 | |
| 71610-904-15 | 71610090415 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-904-15)Marketed from May 6, 2025 | |
| 71610-904-20 | 71610090420 | 20 TABLET, FILM COATED in 1 BOTTLE (71610-904-20)Marketed from May 13, 2025 | |
| 71610-904-28 | 71610090428 | 28 TABLET, FILM COATED in 1 BOTTLE (71610-904-28)Marketed from May 6, 2025 | |
| 71610-904-30 | 71610090430 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-904-30)Marketed from May 6, 2025 | |
| 71610-904-45 | 71610090445 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-904-45)Marketed from May 6, 2025 | |
| 71610-904-53 | 71610090453 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-904-53)Marketed from May 6, 2025 | |
| 71610-904-60 | 71610090460 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-904-60)Marketed from May 6, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Film coated
- Route
- Oral
- 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 71610-904_35d0e953-2920-f36b-e063-6294a90a7d52SPL ID 35d0e953-2920-f36b-e063-6294a90a7d52SPL set ID 349053e4-9885-ec0b-e063-6294a90ad79aRxCUI 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
N471610090410followed by a unit qualifier and the quantityPackage 71610-0904-10. 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.
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 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-848 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-847 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Proficient Rx LP | 71205-691 |
| 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 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-915 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-670 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9684 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-877 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-878 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2303 |
| 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 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9613 |
| Zolpidemzolpidem tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9614 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | The ACME Laboratories Ltd. | 72722-104 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-941 |
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