NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2441Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2441Add 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 NDC11-digit (billing)PackageCopy
72162-2441-172162244101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-1)Marketed from Jan 15, 2025
72162-2441-37216224410330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2441-3)Marketed from Jan 15, 2025

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 — 12.5 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204170
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 72162-2441_5648ce94-ab6e-40c5-a40e-fa90d79e3c89SPL ID 5648ce94-ab6e-40c5-a40e-fa90d79e3c89SPL set ID 8425be72-2bbe-4090-b00e-610f1a1646b1RxCUI 854880UNII 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

N472162244101 followed by a unit qualifier and the quantity

Package 72162-2441-01. 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, USP 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, 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 maintenan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204170

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204170
ProductStrengthForm · routeLabelerProduct NDC
Zolpidem TartrateZolpidem tartrate 6.25 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.47335-307
Zolpidem TartrateZolpidem tartrate 12.5 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.47335-308
Zolpidem TartrateZolpidem tartrate 12.5 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-1468
Zolpidem TartrateZolpidem tartrate 6.25 mg/1Tablet, Film coated, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-913
Zolpidem TartrateZolpidem tartrate 12.5 mg/1Tablet, Film coated, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-254
Zolpidem TartrateZolpidem tartrate 12.5 mg/1Tablet, Film coated, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8376

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