Prescription drug · ANDA
Zolpidem Tartrate NDC 13668-775
Zolpidem tartrate 7.5 mg/1 · Capsule · Oral · TORRENT PHARMACEUTICALS LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-775-30 | 1366807753013668077530 | 30 CAPSULE in 1 BOTTLE (13668-775-30)Marketed from Jun 23, 2026 |
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 — 7.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- TORRENT PHARMACEUTICALS LIMITEDNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220717
- 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 13668-775_56a1fe3a-0093-6ab8-e063-6294a90a6995SPL ID 56a1fe3a-0093-6ab8-e063-6294a90a6995SPL set ID 9025a6f7-5501-4aba-875e-222ef39848c0RxCUI 2637353UNII WY6W63843KUPC 0313668775303
- 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
N413668077530followed by a unit qualifier and the quantityPackage 13668-0775-30. 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 Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration (2.1) and Clinical Studies (14) ] . Zolpidem Tartrate Capsules, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than age 65 years of age ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 13668-775
- What is NDC 13668-775?
- 13668-775 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 7.5 mg/1 capsule, listed with the FDA by TORRENT PHARMACEUTICALS LIMITED. 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?
- TORRENT PHARMACEUTICALS LIMITED, NDC labeler code 13668. 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 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 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | TabletOral | Chartwell RX, LLC | 62135-779 | 62135-0779-90 |
Other NDCs under ANDA 220717
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 7.5 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-089 |