NDC codes

FDA NDC Directory
Product NDC (as listed)71205-639Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0639Add 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
71205-639-30712050639307120506393030 CAPSULE in 1 BOTTLE (71205-639-30)Marketed from Feb 14, 2022
71205-639-60712050639607120506396060 CAPSULE in 1 BOTTLE (71205-639-60)Marketed from Feb 14, 2022
71205-639-90712050639907120506399090 CAPSULE in 1 BOTTLE (71205-639-90)Marketed from Feb 14, 2022

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
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207799
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 71205-639_9cf457c7-9f98-43bc-9ab7-dfea6754ce70SPL ID 9cf457c7-9f98-43bc-9ab7-dfea6754ce70SPL set ID 1503dd3b-688b-4702-8fc1-954b5ffe4235RxCUI 483438UNII 55JG375S6MUPC 0371205639303

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

N471205063930 followed by a unit qualifier and the quantity

Package 71205-0639-30. 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 .

Indications (excerpt from the label)

Pregabalin is 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 is indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) • Postherpetic n…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-639

What is NDC 71205-639?
71205-639 is the product NDC for Pregabalin, Pregabalin 100 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PregabalinPregabalin 225 mg/1CapsuleOralREMEDYREPACK INC.70518-477870518-4778-00
PregabalinPregabalin 200 mg/1CapsuleOralREMEDYREPACK INC.70518-474970518-4749-00
PregabalinPregabalin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-474370518-4743-00
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-471570518-4715-00
PregabalinPregabalin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-471670518-4716-00
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 150 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44329300-0443-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 207799

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

FDA NDC Directory listings under ANDA 207799
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 25 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1462
PregabalinPregabalin 50 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1463
PregabalinPregabalin 75 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1464
PregabalinPregabalin 100 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1465
PregabalinPregabalin 150 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1466
PregabalinPregabalin 200 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1467
PregabalinPregabalin 100 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-681
PregabalinPregabalin 150 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-682
PregabalinPregabalin 200 mg/1CapsuleOralST. MARY'S MEDICAL PARK PHARMACY60760-729
PregabalinPregabalin 25 mg/1CapsuleOralAscend Laboratories, LLC67877-462
PregabalinPregabalin 50 mg/1CapsuleOralAscend Laboratories, LLC67877-463
PregabalinPregabalin 75 mg/1CapsuleOralAscend Laboratories, LLC67877-464
PregabalinPregabalin 100 mg/1CapsuleOralAscend Laboratories, LLC67877-465
PregabalinPregabalin 150 mg/1CapsuleOralAscend Laboratories, LLC67877-466
PregabalinPregabalin 200 mg/1CapsuleOralAscend Laboratories, LLC67877-467
PregabalinPregabalin 225 mg/1CapsuleOralAscend Laboratories, LLC67877-468
PregabalinPregabalin 300 mg/1CapsuleOralAscend Laboratories, LLC67877-469
PregabalinPregabalin 100 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8360
PregabalinPregabalin 75 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8391
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-3597

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