Zolpidem Tartrate NDC 76420-494

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-494Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0494Add 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
76420-494-01	76420049401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-01)Marketed from Oct 5, 2022
76420-494-30	76420049430	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-30)Marketed from Oct 5, 2022
76420-494-60	76420049460	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-60)Marketed from Oct 5, 2022
76420-494-90	76420049490	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-494-90)Marketed from Oct 5, 2022

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 — 6.25 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Asclemed USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213592
Marketing start: Dec 17, 2020
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 76420-494_ea435212-caf8-164b-e053-2a95a90a0bf6SPL ID ea435212-caf8-164b-e053-2a95a90a0bf6SPL set ID 35f6c1ab-a61c-4625-b932-11a7483f1d84RxCUI 854880, 854894UNII 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

N476420049401 followed by a unit qualifier and the quantity

Package 76420-0494-01. 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 Oct 5, 2022. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213592

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

FDA NDC Directory listings under ANDA 213592
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 12.5 mg/1	Tablet, Extended releaseOral	Breckenridge Pharmaceutical, Inc.	51991-982
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-496