What is NDC 71205-816?

71205-816 is the product NDC for Pregabalin, Pregabalin 75 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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 71205-816 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-816Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0816Add 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
71205-816-30	7120508163071205081630	30 CAPSULE in 1 BOTTLE (71205-816-30)Marketed from Jun 22, 2023
71205-816-60	7120508166071205081660	60 CAPSULE in 1 BOTTLE (71205-816-60)Marketed from Jun 22, 2022
71205-816-90	7120508169071205081690	90 CAPSULE in 1 BOTTLE (71205-816-90)Marketed from Jun 22, 2023

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 — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209743
Marketing start: Jul 19, 2019
Listing expires: Dec 31, 2027
DEA schedule: CV
Identifiers: Product ID 71205-816_a17f03ea-9375-48fe-be32-f8df509f5fbaSPL ID a17f03ea-9375-48fe-be32-f8df509f5fbaSPL set ID a17f03ea-9375-48fe-be32-f8df509f5fbaRxCUI 483450UNII 55JG375S6MUPC 0371205816605

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

N471205081630 followed by a unit qualifier and the quantity

Package 71205-0816-30. 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 1, 2023.

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 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN). Error! Hyperlink reference not valid. • Postherpetic neuralgia (PHN) Error! Hyperlink reference not valid. • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Error! Hyperlink refe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-816

What is NDC 71205-816?: 71205-816 is the product NDC for Pregabalin, Pregabalin 75 mg/1 capsule, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 71205. 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 50 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-440	29300-0440-19
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-444	29300-0444-19
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 209743

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

FDA NDC Directory listings under ANDA 209743
Product	Strength	Form · route	Labeler	Product NDC
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1310
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1311
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1312
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1313
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1314
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1315
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1316
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	60219-1317
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1310
Pregabalin	Pregabalin 50 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1311
Pregabalin	Pregabalin 75 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1312
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1313
Pregabalin	Pregabalin 150 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1314
Pregabalin	Pregabalin 200 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1315
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1316
Pregabalin	Pregabalin 300 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1317
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3974
Pregabalin	Pregabalin 100 mg/1	CapsuleOral	Direct_Rx	72189-033
Pregabalin	Pregabalin 225 mg/1	CapsuleOral	Direct_Rx	72189-045
Pregabalin	Pregabalin 25 mg/1	CapsuleOral	Direct_Rx	72189-115

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