NDC codes

FDA NDC Directory
Product NDC (as listed)63187-690Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0690Add 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
63187-690-15631870690156318706901515 TABLET, COATED in 1 BOTTLE (63187-690-15)Marketed from Apr 1, 2016
63187-690-30631870690306318706903030 TABLET, COATED in 1 BOTTLE (63187-690-30)Marketed from Apr 1, 2016
63187-690-60631870690606318706906060 TABLET, COATED in 1 BOTTLE (63187-690-60)Marketed from Apr 1, 2016
63187-690-90631870690906318706909090 TABLET, COATED in 1 BOTTLE (63187-690-90)Marketed from Apr 1, 2016

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 — 10 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077322
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 63187-690_a82182c3-c3b7-4ecb-a223-a921e24cce66SPL ID a82182c3-c3b7-4ecb-a223-a921e24cce66SPL set ID 92c58053-7ed8-4a3d-a2f7-8e30c4e5a367RxCUI 854873, 854876UNII WY6W63843KUPC 0363187691608
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

N463187069015 followed by a unit qualifier and the quantity

Package 63187-0690-15. 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 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. Zolpidem tartrate tablets, USP are a gamma-aminobutyric acid (GABA) A agonist, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-690

What is NDC 63187-690?
63187-690 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 10 mg/1 tablet, coated, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 63187. 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 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
ProductStrengthForm · routeLabelerProduct NDC
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-3739
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralProficient Rx LP63187-691
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralST. MARY'S MEDICAL PARK PHARMACY60760-761
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-8854
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralSandoz Inc0781-5317
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralAdvanced Rx of Tennessee, LLC80425-0513
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, CoatedOralSandoz Inc0781-5318
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, CoatedOralAdvanced Rx of Tennessee, LLC80425-0060
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-9629
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, CoatedOralNorthwind Health Company, LLC82868-078

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