What is NDC 0781-5318?

0781-5318 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 10 mg/1 tablet, coated, listed with the FDA by Sandoz Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. 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 0781-5318 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5318Add 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
0781-5318-01	0078153180100781531801	100 TABLET, COATED in 1 BOTTLE (0781-5318-01)Marketed from Apr 23, 2007
0781-5318-05	0078153180500781531805	500 TABLET, COATED in 1 BOTTLE (0781-5318-05)Marketed from Apr 23, 2007
0781-5318-10	0078153181000781531810	1000 TABLET, COATED in 1 BOTTLE (0781-5318-10)Marketed from Apr 23, 2007
0781-5318-31	0078153183100781531831	30 TABLET, COATED in 1 BOTTLE (0781-5318-31)Marketed from Apr 23, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077322
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 0781-5318_d01ebe6c-e538-4039-8af6-cadae62f6989SPL ID d01ebe6c-e538-4039-8af6-cadae62f6989SPL set ID 0553e26c-f2aa-43aa-adf9-6eb951a501d3RxCUI 854873, 854876UNII WY6W63843KUPC 0307815318017, 0307815318109, 0307815317010, 0307815317102
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

N400781531801 followed by a unit qualifier and the quantity

Package 00781-5318-01. 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 Sep 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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. Zolpidem tartrate tablets are, 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 0781-5318

What is NDC 0781-5318?: 0781-5318 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 10 mg/1 tablet, coated, listed with the FDA by Sandoz Inc. It has 4 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?: Sandoz Inc, NDC labeler code 0781. 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 077322

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

FDA NDC Directory listings under ANDA 077322
Product	Strength	Form · route	Labeler	Product NDC
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-3739
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, CoatedOral	Proficient Rx LP	63187-690
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	Proficient Rx LP	63187-691
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-761
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-8854
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	Sandoz Inc	0781-5317
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	Advanced Rx of Tennessee, LLC	80425-0513
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, CoatedOral	Advanced Rx of Tennessee, LLC	80425-0060
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	71335-9629
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	Tablet, CoatedOral	Northwind Health Company, LLC	82868-078