NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8199Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8199Add 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
63629-8199-16362981990130 CAPSULE in 1 BOTTLE (63629-8199-1)Marketed from Jul 8, 2024
63629-8199-26362981990260 CAPSULE in 1 BOTTLE (63629-8199-2)Marketed from Feb 20, 2020
63629-8199-36362981990390 CAPSULE in 1 BOTTLE (63629-8199-3)Marketed from Jul 31, 2019
63629-8199-46362981990415 CAPSULE in 1 BOTTLE (63629-8199-4)Marketed from Jul 8, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 25 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 63629-8199_153ac768-76ee-4eed-8bf5-b96259836f07SPL ID 153ac768-76ee-4eed-8bf5-b96259836f07SPL set ID 025c3adb-5f6b-45f5-a4c6-cea8e57102e3RxCUI 483442UNII 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

N463629819901 followed by a unit qualifier and the quantity

Package 63629-8199-01. 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 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) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1 ) Fibromyalgia ( 1 ) Neuropathic pain associated with spinal cord injury ( 1 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8199

What is NDC 63629-8199?
63629-8199 is the product NDC for Pregabalin, Pregabalin 25 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 4 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 200 mg/1CapsuleOralREMEDYREPACK INC.70518-474970518-4749-00
PregabalinPregabalin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-474370518-4743-00
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 300 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44629300-0446-19
PregabalinPregabalin 150 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44329300-0443-19
PregabalinPregabalin 200 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44429300-0444-19
PregabalinPregabalin 225 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44529300-0445-19

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
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 225 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-580
PregabalinPregabalin 225 mg/1CapsuleOralProficient Rx LP71205-875
PregabalinPregabalin 100 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-577
PregabalinPregabalin 100 mg/1CapsuleOralProficient Rx LP71205-872
PregabalinPregabalin 150 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-578
PregabalinPregabalin 150 mg/1CapsuleOralProficient Rx LP71205-873
PregabalinPregabalin 200 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-579
PregabalinPregabalin 100 mg/1CapsuleOralProficient Rx LP71205-323
PregabalinPregabalin 200 mg/1CapsuleOralProficient Rx LP71205-874
PregabalinPregabalin 200 mg/1CapsuleOralQuality Care Products, LLC55700-964
PregabalinPregabalin 150 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-507
PregabalinPregabalin 300 mg/1CapsuleOralWestminster Pharmaceuticals, LLC69367-331
PregabalinPregabalin 300 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0177
PregabalinPregabalin 25 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0433
PregabalinPregabalin 50 mg/1CapsuleOralDirect_Rx72189-019
PregabalinPregabalin 75 mg/1CapsuleOralDirect_Rx72189-021
PregabalinPregabalin 75 mg/1CapsuleOralBryant Ranch Prepack71335-2339
PregabalinPregabalin 200 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-754
PregabalinPregabalin 225 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-995
PregabalinPregabalin 25 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-993

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