Prescription drug · ANDA
Zolpidem Tartrate NDC 55700-357
Zolpidem tartrate 10 mg/1 · Tablet · Oral · Lake Erie Medical DBA Quality Care Products LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55700-357-30 | 5570003573055700035730 | 30 TABLET in 1 BOTTLE (55700-357-30)Marketed from Jan 13, 2016 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lake Erie Medical DBA Quality Care Products LLCNDC labeler code 55700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077903
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 55700-357_441aafa7-9b54-4c40-8339-afb197dab6e0SPL ID 441aafa7-9b54-4c40-8339-afb197dab6e0SPL set ID db735db9-1c82-4d32-bf91-97b05a75e876RxCUI 854873UNII 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
N455700035730followed by a unit qualifier and the quantityPackage 55700-0357-30. 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 .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Zolpidem tartrate tablets, USP are gamma-amino butyric acid (GABA) A agonist, 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. ( 1) 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 4-5 weeks in…
Excerpt only. Read the full label for complete information.
About NDC 55700-357
- What is NDC 55700-357?
- 55700-357 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 10 mg/1 tablet, listed with the FDA by Lake Erie Medical DBA Quality Care Products LLC. 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?
- Lake Erie Medical DBA Quality Care Products LLC, NDC labeler code 55700. 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?
- 116 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 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5804 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-1398 |
| 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 |
Showing 20 of 32.