NDC codes

FDA NDC Directory
Product NDC (as listed)63187-114Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0114Add 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
63187-114-30631870114306318701143030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-114-30)Marketed from Jan 1, 2019

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 — 12.5 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090107
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)Pyridines (Chemical structure)
Identifiers
Product ID 63187-114_8cc5ab2b-822e-4d2b-b325-43842fdb685bSPL ID 8cc5ab2b-822e-4d2b-b325-43842fdb685bSPL set ID 25e71199-c55d-4cc6-8388-b309d654d2b0RxCUI 854880UNII WY6W63843K
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

N463187011430 followed by a unit qualifier and the quantity

Package 63187-0114-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 63187-114

What is NDC 63187-114?
63187-114 is the product NDC for Zolpidem tartrate, Zolpidem tartrate 12.5 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. It has 1 package NDC, 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 090107

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

FDA NDC Directory listings under ANDA 090107
ProductStrengthForm · routeLabelerProduct NDC
Zolpidem tartrateZolpidem tartrate 6.25 mg/1Tablet, Extended releaseOralSandoz Inc0781-5315
Zolpidem tartrateZolpidem tartrate 12.5 mg/1Tablet, Extended releaseOralSandoz Inc0781-5316
Zolpidem tartrateZolpidem tartrate 12.5 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-4597
Zolpidem tartrateZolpidem tartrate 6.25 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-4708

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