Zolpidem tartrate NDC 63187-114

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-114Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0114Add 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	Copy
63187-114-30	63187011430	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-114-30)Marketed from Jan 1, 2019

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: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090107
Marketing start: Oct 31, 2011
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)Pyridines (Chemical structure)
Identifiers: Product ID 63187-114_8cc5ab2b-822e-4d2b-b325-43842fdb685bSPL ID 8cc5ab2b-822e-4d2b-b325-43842fdb685bSPL set ID 25e71199-c55d-4cc6-8388-b309d654d2b0RxCUI 854880UNII WY6W63843K
Pharmacologic class: gamma-Aminobutyric Acid-ergic Agonist

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

N463187011430 followed by a unit qualifier and the quantity

Package 63187-0114-30. 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 Jan 1, 2021.

Indications (excerpt from the label)

1INDICATIONS AND USAGE Zolpidem tartrate extended-release tablet, USP is indicated for the 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 tablet, USP a gamma-aminobutyric acid (GABA) A agonist, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maint…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090107

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

FDA NDC Directory listings under ANDA 090107
Product	Strength	Form · route	Labeler	Product NDC
Zolpidem tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-4597
Zolpidem tartrate	Zolpidem tartrate 6.25 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-4708
Zolpidem tartrate	Zolpidem tartrate 6.25 mg/1	Tablet, Extended releaseOral	Sandoz Inc	0781-5315
Zolpidem tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Extended releaseOral	Sandoz Inc	0781-5316