Prescription drug · ANDA
Zolpidem Tartrate NDC 51991-982
Zolpidem tartrate 12.5 mg/1 · Tablet, Extended release · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-982-01 | 5199109820151991098201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-982-01)Marketed from May 18, 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 — 12.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213592
- 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 51991-982_cc8bcec1-aa3c-4125-884e-207bea54d5b1SPL ID cc8bcec1-aa3c-4125-884e-207bea54d5b1SPL set ID cbda91f7-4411-4016-80d6-0a349931956dRxCUI 854880, 854894UNII WY6W63843KUPC 0351991982012, 0351991981015
- 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
N451991098201followed by a unit qualifier and the quantityPackage 51991-0982-01. 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 extended-release tablets are 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) ]. Zolpidem tartrate extended-release tablets, 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/…
Excerpt only. Read the full label for complete information.
About NDC 51991-982
- What is NDC 51991-982?
- 51991-982 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 12.5 mg/1 tablet, extended release, listed with the FDA by Breckenridge Pharmaceutical, Inc.. 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?
- Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. 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 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 213592
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 6.25 mg/1 | Tablet, Extended releaseOral | Breckenridge Pharmaceutical, Inc. | 51991-981 |
| Zolpidem Tartrate | Zolpidem tartrate 6.25 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-494 |
| Zolpidem Tartrate | Zolpidem tartrate 12.5 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-496 |