Prescription drug · NDA
zolpidem tartrate NDC 52427-775
Zolpidem tartrate 7.5 mg/1 · Capsule · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-775-30 | 52427077530 | 30 CAPSULE in 1 BOTTLE (52427-775-30)Marketed from May 24, 2023 |
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
- Almatica Pharma LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215721
- 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 52427-775_1de7823f-3d49-f5ef-f98b-6d34d2419daeSPL ID 1de7823f-3d49-f5ef-f98b-6d34d2419daeSPL set ID 2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916RxCUI 2637353UNII WY6W63843KUPC 0352427775307
- 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
N452427077530followed by a unit qualifier and the quantityPackage 52427-0775-30. 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 65 years of age ( 1 )
Excerpt only. Read the full label for complete information.
- openFDA data updated
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