What is NDC 80425-0165?

80425-0165 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 5 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy 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?

117 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 80425-0165 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0165Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0165Add 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
80425-0165-1	80425016501	30 TABLET in 1 BOTTLE (80425-0165-1)Marketed from Sep 5, 2007
80425-0165-2	80425016502	60 TABLET in 1 BOTTLE (80425-0165-2)Marketed from Sep 5, 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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
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 80425-0165_2a99b1dd-bed1-79f9-e063-6394a90a35f3SPL ID 2a99b1dd-bed1-79f9-e063-6394a90a35f3SPL set ID c8adec28-9dcd-4a7e-e053-2a95a90a991eRxCUI 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

N480425016501 followed by a unit qualifier and the quantity

Package 80425-0165-01. 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)

About NDC 80425-0165

What is NDC 80425-0165?: 80425-0165 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 5 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 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 Pharmacy 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?: 117 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 118 Zolpidem Tartrate NDCs

Other NDCs under ANDA 077903

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

FDA NDC Directory listings under ANDA 077903
Product	Strength	Form · route	Labeler	Product NDC
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Major Pharmaceuticals	0904-6082
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-007
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-008
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Calvin Scott & Co., Inc.	17224-970
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	A-S Medication Solutions	50090-1022
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	A-S Medication Solutions	50090-1023
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	A-S Medication Solutions	50090-5804
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-1398
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Lake Erie Medical DBA Quality Care Products LLC	55700-357
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-288
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-515
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	DirectRX	61919-663
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Direct_Rx	61919-751
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Proficient Rx LP	63187-558
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Proficient Rx LP	63187-565
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-3549
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc	68071-1887
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2232
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4598
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5063

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