What is NDC 80425-0061?

80425-0061 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 10 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zolpidem Tartrate?

116 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zolpidem Tartrate NDC 80425-0061 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0061Add 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
80425-0061-1	8042500610180425006101	30 TABLET, FILM COATED in 1 BOTTLE (80425-0061-1)Marketed from May 4, 2007
80425-0061-2	8042500610280425006102	60 TABLET, FILM COATED in 1 BOTTLE (80425-0061-2)Marketed from May 4, 2007
80425-0061-3	8042500610380425006103	90 TABLET, FILM COATED in 1 BOTTLE (80425-0061-3)Marketed from May 4, 2007

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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078413
Marketing start: May 4, 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 80425-0061_2a98ff70-0363-7169-e063-6394a90adc74SPL ID 2a98ff70-0363-7169-e063-6394a90adc74SPL set ID af87df4e-2c97-e23e-e053-2a95a90ab354RxCUI 854873UNII 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

N480425006101 followed by a unit qualifier and the quantity

Package 80425-0061-01. 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 1 INDICATIONS AND USAGE Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets 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)

About NDC 80425-0061

What is NDC 80425-0061?: 80425-0061 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 10 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zolpidem Tartrate.
What is the active ingredient?: Zolpidem tartrate.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zolpidem Tartrate?: 116 other product NDCs are listed under this name. See all Zolpidem Tartrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zolpidem Tartrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zolpidem Tartrate	Zolpidem tartrate 7.5 mg/1	CapsuleOral	TORRENT PHARMACEUTICALS LIMITED	13668-775	13668-0775-30
Zolpidem Tartrate	Zolpidem tartrate 6.25 mg/1	Tablet, Extended releaseOral	Breckenridge Pharmaceutical, Inc.	51991-981	51991-0981-01
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Extended releaseOral	Breckenridge Pharmaceutical, Inc.	51991-982	51991-0982-01
Zolpidem Tartrate	Zolpidem tartrate 7.5 mg/1	CapsuleOral	Umedica Laboratories USA Inc.	60290-089	60290-0089-0160290-0089-02
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, CoatedOral	Northwind Health Company, LLC	82868-078	82868-0078-30
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	Advanced Rx of Tennessee, LLC	80425-0513	80425-0513-0180425-0513-0280425-0513-03
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8854	68788-8854-0368788-8854-06
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-838	60687-0838-01
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Extended releaseOral	St. Mary's Medical Park Pharmacy	60760-819	60760-0819-30
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Chartwell RX, LLC	62135-778	62135-0778-90

All 117 Zolpidem Tartrate NDCs

Other NDCs under ANDA 078413

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

FDA NDC Directory listings under ANDA 078413
Product	Strength	Form · route	Labeler	Product NDC
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-621
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-622
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2649
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3878
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3879
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5095
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6070
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7434
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-838
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-159
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3770
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3943
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-151
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-152
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-156
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-192
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-323
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-390
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-416
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-417

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