What is NDC 63187-558?

63187-558 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 5 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zolpidem Tartrate NDC 63187-558 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-558Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0558Add 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
63187-558-05	6318705580563187055805	5 TABLET in 1 BOTTLE (63187-558-05)Marketed from Feb 1, 2019
63187-558-15	6318705581563187055815	15 TABLET in 1 BOTTLE (63187-558-15)Marketed from Dec 1, 2018
63187-558-30	6318705583063187055830	30 TABLET in 1 BOTTLE (63187-558-30)Marketed from Dec 1, 2018
63187-558-60	6318705586063187055860	60 TABLET in 1 BOTTLE (63187-558-60)Marketed from Dec 1, 2018
63187-558-90	6318705589063187055890	90 TABLET in 1 BOTTLE (63187-558-90)Marketed from Dec 1, 2018

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: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077903
Marketing start: Sep 5, 2007
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 63187-558_abcdf937-6cde-4adf-97fe-599ac82e20f1SPL ID abcdf937-6cde-4adf-97fe-599ac82e20f1SPL set ID e1f43bde-efba-42be-adef-94e1ef6664fdRxCUI 854876UNII WY6W63843KUPC 0363187558604
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

N463187055805 followed by a unit qualifier and the quantity

Package 63187-0558-05. 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 Apr 1, 2022.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Zolpidem tartrate tablets, USP are gamma-amino butyric acid (GABA) A agonist, 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. ( 1) 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 4-5 weeks in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-558

What is NDC 63187-558?: 63187-558 is the product NDC for Zolpidem Tartrate, Zolpidem tartrate 5 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 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
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 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
Product	Strength	Form · route	Labeler	Product NDC
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Major Pharmaceuticals	0904-6082
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-007
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-008
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Calvin Scott & Co., Inc.	17224-970
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	A-S Medication Solutions	50090-1022
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	A-S Medication Solutions	50090-1023
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	A-S Medication Solutions	50090-5804
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-1398
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Lake Erie Medical DBA Quality Care Products LLC	55700-357
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-288
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-515
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	DirectRX	61919-663
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Direct_Rx	61919-751
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Proficient Rx LP	63187-565
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-3549
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc	68071-1887
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2232
Zolpidem Tartrate	Zolpidem tartrate 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4598
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5063
Zolpidem Tartrate	Zolpidem tartrate 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5093

Showing 20 of 32.