What is NDC 76420-122?

76420-122 is the product NDC for Pregabalin, Pregabalin 200 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 76420-122 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-122Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0122Add 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
76420-122-30	76420012230	30 CAPSULE in 1 BOTTLE (76420-122-30)Marketed from Jun 25, 2020
76420-122-60	76420012260	60 CAPSULE in 1 BOTTLE (76420-122-60)Marketed from Jun 25, 2020
76420-122-90	76420012290	90 CAPSULE in 1 BOTTLE (76420-122-90)Marketed from Jun 25, 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 — 200 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 210432
Marketing start: Jul 19, 2019
Listing expires: Dec 31, 2026
DEA schedule: CV
Identifiers: Product ID 76420-122_a8e4e23f-490f-7ebc-e053-2a95a90af171SPL ID a8e4e23f-490f-7ebc-e053-2a95a90af171SPL set ID 69b8a843-a3a8-4d76-8418-f48288625030RxCUI 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

N476420012230 followed by a unit qualifier and the quantity

Package 76420-0122-30. 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 Jun 25, 2020.

Indications (excerpt from the label)

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 diabetic peripheral neuropathy (DPN) (1 ) Postherpe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-122

What is NDC 76420-122?: 76420-122 is the product NDC for Pregabalin, Pregabalin 200 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 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 100 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-442	29300-0442-19
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-439	29300-0439-19
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 300 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-446	29300-0446-19
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-443	29300-0443-19
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-444	29300-0444-19
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-445	29300-0445-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 210432

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

FDA NDC Directory listings under ANDA 210432
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7001
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1505
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7002
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7003
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7004
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-120
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-117
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-118
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-119
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7005
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-124
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-121
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-123
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2304
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-410
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Quality Care Products, LLC	55700-774
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-414
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-411
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-412
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Quality Care Products, LLC	55700-773

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