Prescription drug · NDA
Ambien CR (Zolpidem tartrate) NDC 0713-5501
Zolpidem tartrate 6.25 mg/1 · Tablet, Coated · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-5501-01 | 0071355010100713550101 | 100 TABLET, COATED in 1 BOTTLE (0713-5501-01)Marketed from Feb 7, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Ambien CRSuffix: CR
- Generic name (nonproprietary)
- zolpidem tartrate
- Active ingredients
- Zolpidem tartrate — 6.25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021774
- 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 0713-5501_2d9350bd-56ea-7273-e063-6394a90a0e61SPL ID 2d9350bd-56ea-7273-e063-6394a90a0e61SPL set ID 2d934da3-bd77-4470-e063-6294a90a64f5RxCUI 854880, 854882, 854894, 854896UNII 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
N400713550101followed by a unit qualifier and the quantityPackage 00713-5501-01. 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)
AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient reported assessment in adult patients only) in duration [see Clinical Studies (14) ]. AMBIEN CR, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. …
Excerpt only. Read the full label for complete information.
About NDC 0713-5501
- What is NDC 0713-5501?
- 0713-5501 is the product NDC for Ambien CR (zolpidem tartrate), Zolpidem tartrate 6.25 mg/1 tablet, coated, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ambien CR (Zolpidem tartrate).
- What is the active ingredient?
- Zolpidem tartrate.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ambien CR?
- 1 other product NDC are listed under this name. See all Ambien CR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ambien CR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ambien CRzolpidem tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, CoatedOral | Cosette Pharmaceuticals, Inc. | 0713-5521 | 00713-5521-01 |
Other NDCs under NDA 021774
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 |
|---|---|---|---|---|
| Ambien CRzolpidem tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, CoatedOral | Cosette Pharmaceuticals, Inc. | 0713-5521 |
| zolpidem tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-761 |
| zolpidem tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, CoatedOral | Golden State Medical Supply, Inc. | 51407-762 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-862 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-770 |