NDC codes

FDA NDC Directory
Product NDC (as listed)69367-331Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0331Add 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
69367-331-09693670331096936703310990 CAPSULE in 1 BOTTLE (69367-331-09)Marketed from Aug 24, 2021

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 — 300 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Westminster Pharmaceuticals, LLCNDC labeler code 69367
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 69367-331_0efc2eea-ebae-47f9-a13a-f2df4331cf04SPL ID 0efc2eea-ebae-47f9-a13a-f2df4331cf04SPL set ID 781cb1ac-a0d2-4b47-b319-f0b90de86384RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0369367328098, 0369367330091, 0369367327091, 0369367326094, 0369367325097, 0369367324090, 0369367331098, 0369367329095

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

N469367033109 followed by a unit qualifier and the quantity

Package 69367-0331-09. 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 69367-331

What is NDC 69367-331?
69367-331 is the product NDC for Pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, 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?
Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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?
503 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 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 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19
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
PregabalinPregabalin 300 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44629300-0446-19

All 504 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 50 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-351
PregabalinPregabalin 25 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-350
PregabalinPregabalin 150 mg/1CapsuleOralBryant Ranch Prepack71335-3118
PregabalinPregabalin 75 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7522
PregabalinPregabalin 25 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7520
PregabalinPregabalin 50 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7521
PregabalinPregabalin 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0277
PregabalinPregabalin 100 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7523
PregabalinPregabalin 150 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7524
PregabalinPregabalin 300 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-800
PregabalinPregabalin 200 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7527
PregabalinPregabalin 75 mg/1CapsuleOralA-S Medication Solutions50090-5038
PregabalinPregabalin 75 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-799
PregabalinPregabalin 200 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-355
PregabalinPregabalin 225 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-356
PregabalinPregabalin 75 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0028
PregabalinPregabalin 300 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-357
PregabalinPregabalin 150 mg/1CapsuleOralProficient Rx LP71205-396
PregabalinPregabalin 300 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7656
PregabalinPregabalin 50 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-820

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