Prescription drug · ANDA
Zolpidem Tartrate NDC 50090-5804
Zolpidem tartrate 10 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5804-0 | 50090580400 | 90 TABLET in 1 BOTTLE (50090-5804-0)Marketed from Oct 15, 2021 |
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
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- 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 Agonists (Mechanism)Pyridines (Chemical structure)
- Identifiers
- Product ID 50090-5804_1f6ac937-6707-4d59-846e-532afcfd45d1SPL ID 1f6ac937-6707-4d59-846e-532afcfd45d1SPL set ID e68a1b3b-b3d1-495e-be46-466113e7dbd6RxCUI 854873UNII 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
N450090580400followed by a unit qualifier and the quantityPackage 50090-5804-00. 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, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. 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.
About NDC 50090-5804
- What is NDC 50090-5804?
- 50090-5804 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 10 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zolpidem Tartrate.
- What is the active ingredient?
- Zolpidem tartrate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 Tartrate?
- 117 other product NDCs are listed under this name. See all Zolpidem Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zolpidem Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zolpidem Tartrate | Zolpidem tartrate 7.5 mg/1 | CapsuleOral | TORRENT PHARMACEUTICALS LIMITED | 13668-775 | 13668-0775-30 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-981 | 51991-0981-01 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-982 | 51991-0982-01 |
| Zolpidem Tartrate | Zolpidem tartrate 7.5 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-089 | 60290-0089-0160290-0089-02 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 82868-078 | 82868-0078-30 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0513 | 80425-0513-0180425-0513-0280425-0513-03 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8854 | 68788-8854-0368788-8854-06 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-838 | 60687-0838-01 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-819 | 60760-0819-30 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-778 | 62135-0778-90 |
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 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6082 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-007 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-008 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-970 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-1022 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1023 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-1398 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Lake Erie Medical DBA Quality Care Products LLC | 55700-357 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-288 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-515 |
| 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 | Proficient Rx LP | 63187-558 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Proficient Rx LP | 63187-565 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3549 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc | 68071-1887 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2232 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4598 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5063 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5093 |
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