Prescription drug · ANDA
Zolpidem Tartrate NDC 60290-089
Zolpidem tartrate 7.5 mg/1 · Capsule · Oral · Umedica Laboratories USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60290-089-01 | 6029000890160290008901 | 30 CAPSULE in 1 BOTTLE (60290-089-01)Marketed from May 14, 2026 | |
| 60290-089-02 | 6029000890260290008902 | 1000 CAPSULE in 1 BOTTLE (60290-089-02)Marketed from May 14, 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
- Umedica Laboratories USA Inc.NDC labeler code 60290
- 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 60290-089_52b460fd-06b6-613d-e063-6294a90ac977SPL ID 52b460fd-06b6-613d-e063-6294a90ac977SPL set ID b49f6c18-e155-4728-a79a-9354e8c3c8f4RxCUI 2637353UNII WY6W63843KUPC 0360290089018
- 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
N460290008901followed by a unit qualifier and the quantityPackage 60290-0089-01. 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 60290-089
- What is NDC 60290-089?
- 60290-089 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 7.5 mg/1 capsule, listed with the FDA by Umedica Laboratories USA Inc.. It has 2 package NDCs, 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?
- Umedica Laboratories USA Inc., NDC labeler code 60290. 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 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 | TORRENT PHARMACEUTICALS LIMITED | 13668-775 |