What is NDC 76420-098?

76420-098 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pregabalin?

509 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pregabalin NDC 76420-098 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-098Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0098Add 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
76420-098-30	7642000983076420009830	30 CAPSULE in 1 BOTTLE (76420-098-30)Marketed from Jun 17, 2020
76420-098-60	7642000986076420009860	60 CAPSULE in 1 BOTTLE (76420-098-60)Marketed from Jun 17, 2020
76420-098-90	7642000989076420009890	90 CAPSULE in 1 BOTTLE (76420-098-90)Marketed from Jun 17, 2020

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): Pregabalin
Generic name (nonproprietary): pregabalin
Active ingredients: Pregabalin — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start: Jul 19, 2019
Listing expires: Dec 31, 2027
DEA schedule: CV
Identifiers: Product ID 76420-098_ead3b1c9-5c7d-457b-e053-2995a90a71efSPL ID ead3b1c9-5c7d-457b-e053-2995a90a71efSPL set ID 3d2464fb-b3ac-496e-b8a5-c2e8a902ce29RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6M

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

N476420009830 followed by a unit qualifier and the quantity

Package 76420-0098-30. 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

Current FDA label (SPL), effective Oct 12, 2022.

Indications (excerpt from the label)

Pregabalin capsules are indicated for:Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin capsules are indicated for: Neuropathic pain associated with dia…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-098

What is NDC 76420-098?: 76420-098 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pregabalin.
What is the active ingredient?: Pregabalin.
Who is the labeler?: Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pregabalin?: 509 other product NDCs are listed under this name. See all Pregabalin 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 Pregabalin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4778	70518-4778-00
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4749	70518-4749-00
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4743	70518-4743-00
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4715	70518-4715-00
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4716	70518-4716-00
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-439	29300-0439-19
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-443	29300-0443-19
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-440	29300-0440-19
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-441	29300-0441-19
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-442	29300-0442-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 208677

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

FDA NDC Directory listings under ANDA 208677
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-930
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-931
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8239
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-894
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc	50228-652
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8248
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	53401-007
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Direct_Rx	72189-241
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Quality Care Products, LLC	55700-964
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1543
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0433
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1541
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1542
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1544
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Direct_Rx	72189-251
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0177
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1545
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1546
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-577
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1547

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