Prescription drug · ANDA
Zolpidem Tartrate NDC 71610-156
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 |
|---|---|---|---|
| 71610-156-30 | 71610015630 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-156-30)Marketed from Sep 20, 2018 |
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 078413
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)Pyridines (Chemical structure)
- Identifiers
- Product ID 71610-156_054ab49e-270f-497f-a5ed-a46264e5e282SPL ID 054ab49e-270f-497f-a5ed-a46264e5e282SPL set ID 7be7f243-e6f8-406f-aed7-be7cedd5630aRxCUI 854876UNII WY6W63843K
- Pharmacologic class
- gamma-Aminobutyric Acid-ergic Agonist
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
N471610015630followed by a unit qualifier and the quantityPackage 71610-0156-30. 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 are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets 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. Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) A agonist, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078413
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 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-838 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-323 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7434 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-151 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6070 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-152 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3943 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-192 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-390 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-416 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-417 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0061 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0087 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3878 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3770 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3879 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5095 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2649 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-621 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-622 |
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