What is NDC 47335-307?

47335-307 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 6.25 mg/1 tablet, film coated, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 47335-307 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-307Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0307Add 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
47335-307-13	4733503071347335030713	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-13)Marketed from May 15, 2017
47335-307-88	4733503078847335030788	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-307-88)Marketed from May 15, 2017

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, Film coated, Extended release
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204170
Marketing start: May 15, 2017
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)Pyridines (Chemical structure)
Identifiers: Product ID 47335-307_4a5c474b-e752-4d01-be37-a66e7c9bf62eSPL ID 4a5c474b-e752-4d01-be37-a66e7c9bf62eSPL set ID 0c64bc71-2e7f-4b15-a8e1-acb8de04395fRxCUI 854880, 854894UNII WY6W63843KUPC 0347335307887, 0347335308884
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

N447335030713 followed by a unit qualifier and the quantity

Package 47335-0307-13. 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 18, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Zolpidem tartrate extended-release tablets, USP 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, 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/or sleep maintenan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-307

What is NDC 47335-307?: 47335-307 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 6.25 mg/1 tablet, film coated, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 204170

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

FDA NDC Directory listings under ANDA 204170
Product	Strength	Form · route	Labeler	Product NDC
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-308
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-8376
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-1468
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-254
Zolpidem Tartrate	Zolpidem tartrate 6.25 mg/1	Tablet, Film coated, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-913
Zolpidem Tartrate	Zolpidem tartrate 12.5 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	72162-2441