Zolpidem Tartrate NDC 80425-0322

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0322Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0322Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
80425-0322-1	80425032201	30 TABLET in 1 BOTTLE (80425-0322-1)Marketed from Apr 13, 2023
80425-0322-2	80425032202	60 TABLET in 1 BOTTLE (80425-0322-2)Marketed from Apr 13, 2023
80425-0322-3	80425032203	90 TABLET in 1 BOTTLE (80425-0322-3)Marketed from Apr 13, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077903
Marketing start: Sep 5, 2007
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
Identifiers: Product ID 80425-0322_2a9bfe6a-6d6f-b262-e063-6294a90a1cf3SPL ID 2a9bfe6a-6d6f-b262-e063-6294a90a1cf3SPL set ID f939549f-14a6-d37c-e053-6294a90a034aRxCUI 854876UNII 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

N480425032201 followed by a unit qualifier and the quantity

Package 80425-0322-01. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1. Indications and Usage Section INDICATIONS AND USAGE Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see CLINICAL STUDIES (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)