NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7005Add 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
0904-7005-040090470050430 BLISTER PACK in 1 CARTON (0904-7005-04) / 1 CAPSULE in 1 BLISTER PACKMarketed from Jul 19, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210432
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 0904-7005_ce6f3554-3f28-4d2e-8f32-e0893f1f43a5SPL ID ce6f3554-3f28-4d2e-8f32-e0893f1f43a5SPL set ID 2420e2d7-c01a-4590-88c5-6fe5361747e9RxCUI 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

N400904700504 followed by a unit qualifier and the quantity

Package 00904-7005-04. 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 0904-7005

What is NDC 0904-7005?
0904-7005 is the product NDC for Pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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?
507 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 508 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
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 200 mg/1CapsuleOralBryant Ranch Prepack71335-1555
PregabalinPregabalin 300 mg/1CapsuleOralBryant Ranch Prepack71335-1505
PregabalinPregabalin 100 mg/1CapsuleOralCardinal Health 107, LLC55154-4308
PregabalinPregabalin 50 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0027
PregabalinPregabalin 75 mg/1CapsuleOralA-S Medication Solutions50090-6793
PregabalinPregabalin 75 mg/1CapsuleOralMajor Pharmaceuticals0904-7000
PregabalinPregabalin 225 mg/1CapsuleOralREMEDYREPACK INC.70518-4569
PregabalinPregabalin 100 mg/1CapsuleOralMajor Pharmaceuticals0904-7001
PregabalinPregabalin 150 mg/1CapsuleOralBryant Ranch Prepack72162-2304
PregabalinPregabalin 200 mg/1CapsuleOralMajor Pharmaceuticals0904-7003
PregabalinPregabalin 225 mg/1CapsuleOralMajor Pharmaceuticals0904-7004
PregabalinPregabalin 25 mg/1CapsuleOralAsclemed USA, Inc.76420-117
PregabalinPregabalin 150 mg/1CapsuleOralAsclemed USA, Inc.76420-121
PregabalinPregabalin 50 mg/1CapsuleOralAsclemed USA, Inc.76420-118
PregabalinPregabalin 75 mg/1CapsuleOralAsclemed USA, Inc.76420-119
PregabalinPregabalin 100 mg/1CapsuleOralAsclemed USA, Inc.76420-120
PregabalinPregabalin 200 mg/1CapsuleOralAsclemed USA, Inc.76420-122
PregabalinPregabalin 225 mg/1CapsuleOralAsclemed USA, Inc.76420-123
PregabalinPregabalin 300 mg/1CapsuleOralAsclemed USA, Inc.76420-124
PregabalinPregabalin 25 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-410

Showing 20 of 39.

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