What is NDC 71610-904?

71610-904 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 5 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 9 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-904 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-904Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0904Add 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
71610-904-10	7161009041071610090410	10 TABLET, FILM COATED in 1 BOTTLE (71610-904-10)Marketed from May 6, 2025
71610-904-14	7161009041471610090414	14 TABLET, FILM COATED in 1 BOTTLE (71610-904-14)Marketed from May 6, 2025
71610-904-15	7161009041571610090415	15 TABLET, FILM COATED in 1 BOTTLE (71610-904-15)Marketed from May 6, 2025
71610-904-20	7161009042071610090420	20 TABLET, FILM COATED in 1 BOTTLE (71610-904-20)Marketed from May 13, 2025
71610-904-28	7161009042871610090428	28 TABLET, FILM COATED in 1 BOTTLE (71610-904-28)Marketed from May 6, 2025
71610-904-30	7161009043071610090430	30 TABLET, FILM COATED in 1 BOTTLE (71610-904-30)Marketed from May 6, 2025
71610-904-45	7161009044571610090445	45 TABLET, FILM COATED in 1 BOTTLE (71610-904-45)Marketed from May 6, 2025
71610-904-53	7161009045371610090453	60 TABLET, FILM COATED in 1 BOTTLE (71610-904-53)Marketed from May 6, 2025
71610-904-60	7161009046071610090460	90 TABLET, FILM COATED in 1 BOTTLE (71610-904-60)Marketed from May 6, 2025

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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077214
Marketing start: Apr 23, 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 71610-904_35d0e953-2920-f36b-e063-6294a90a7d52SPL ID 35d0e953-2920-f36b-e063-6294a90a7d52SPL set ID 349053e4-9885-ec0b-e063-6294a90ad79aRxCUI 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

N471610090410 followed by a unit qualifier and the quantity

Package 71610-0904-10. 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 May 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has 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 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-904

What is NDC 71610-904?: 71610-904 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 5 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 9 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 077214

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

FDA NDC Directory listings under ANDA 077214
Product	Strength	Form · route	Labeler	Product NDC
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1170
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-8998
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-8999
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-9613
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-9614
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	ACI Healthcare USA, Inc	71093-155
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	ACI Healthcare USA, Inc	71093-156
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Proficient Rx LP	71205-691
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2303
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-9684
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-670
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-847
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-848
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-1982
Zolpidemzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-1983
Zolpidemzolpidem tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0430
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-941
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-942
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-915
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, Film coatedOral	The ACME Laboratories Ltd.	72722-103

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