NDC codes

FDA NDC Directory
Product NDC (as listed)13668-007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0007Add 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 NDC11-digit (billing)PackageCopy
13668-007-011366800070113668000701100 TABLET in 1 BOTTLE (13668-007-01)Marketed from Sep 5, 2007
13668-007-051366800070513668000705500 TABLET in 1 BOTTLE (13668-007-05)Marketed from Sep 5, 2007
13668-007-1013668000710136680007101000 TABLET in 1 BOTTLE (13668-007-10)Marketed from Sep 5, 2007
13668-007-1513668000715136680007151500 TABLET in 1 BOTTLE (13668-007-15)Marketed from Sep 5, 2007
13668-007-30136680007301366800073030 TABLET in 1 BOTTLE (13668-007-30)Marketed from Sep 5, 2007
13668-007-90136680007901366800079090 TABLET in 1 BOTTLE (13668-007-90)Marketed from Sep 5, 2007

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
Route
Oral
Labeler
Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077903
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
Identifiers
Product ID 13668-007_d9481da2-be07-4d0e-8316-9bea2dc953ceSPL ID d9481da2-be07-4d0e-8316-9bea2dc953ceSPL set ID 1584bad1-7bf4-4805-bdd9-7eb0fac92721RxCUI 854873, 854876UNII WY6W63843KUPC 0313668008302, 0313668007305
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

N413668000701 followed by a unit qualifier and the quantity

Package 13668-0007-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. 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 13668-007

What is NDC 13668-007?
13668-007 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 5 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 6 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?
Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Zolpidem TartrateZolpidem tartrate 7.5 mg/1CapsuleOralTORRENT PHARMACEUTICALS LIMITED13668-77513668-0775-30
Zolpidem TartrateZolpidem tartrate 6.25 mg/1Tablet, Extended releaseOralBreckenridge Pharmaceutical, Inc.51991-98151991-0981-01
Zolpidem TartrateZolpidem tartrate 12.5 mg/1Tablet, Extended releaseOralBreckenridge Pharmaceutical, Inc.51991-98251991-0982-01
Zolpidem TartrateZolpidem tartrate 7.5 mg/1CapsuleOralUmedica Laboratories USA Inc.60290-08960290-0089-0160290-0089-02
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, CoatedOralNorthwind Health Company, LLC82868-07882868-0078-30
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralAdvanced Rx of Tennessee, LLC80425-051380425-0513-0180425-0513-0280425-0513-03
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-885468788-8854-0368788-8854-06
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-83860687-0838-01
Zolpidem TartrateZolpidem tartrate 12.5 mg/1Tablet, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-81960760-0819-30
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralChartwell RX, LLC62135-77862135-0778-90

All 117 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
ProductStrengthForm · routeLabelerProduct NDC
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralMajor Pharmaceuticals0904-6082
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralTorrent Pharmaceuticals Limited13668-008
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralCalvin Scott & Co., Inc.17224-970
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralA-S Medication Solutions50090-1022
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralA-S Medication Solutions50090-1023
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralA-S Medication Solutions50090-5804
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralCardinal Health 107, LLC55154-1398
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralLake Erie Medical DBA Quality Care Products LLC55700-357
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-288
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-515
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralDirectRX61919-663
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralDirect_Rx61919-751
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralProficient Rx LP63187-558
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralProficient Rx LP63187-565
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralBryant Ranch Prepack63629-3549
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralNuCare Pharmaceuticals, Inc68071-1887
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2232
Zolpidem TartrateZolpidem tartrate 5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4598
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5063
Zolpidem TartrateZolpidem tartrate 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5093

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