NDC codes

FDA NDC Directory
Product NDC (as listed)55154-4308Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-4308Add 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
55154-4308-0551544308005515443080010 BLISTER PACK in 1 BAG (55154-4308-0) / 1 CAPSULE in 1 BLISTER PACKMarketed from Jul 19, 2019

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 — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Cardinal Health 107, LLCNDC labeler code 55154
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 55154-4308_1beff966-c4e8-43f6-92d5-67c5fbbd8e3eSPL ID 1beff966-c4e8-43f6-92d5-67c5fbbd8e3eSPL set ID 124176c7-d8ab-4bbe-b468-3e5d12f03e44RxCUI 483438, 483448, 483450UNII 55JG375S6MUPC 0055154809801, 0055154430807

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

N455154430800 followed by a unit qualifier and the quantity

Package 55154-4308-00. 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 55154-4308

What is NDC 55154-4308?
55154-4308 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Cardinal Health 107, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 200 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44429300-0444-19
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 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 300 mg/1CapsuleOralMajor Pharmaceuticals0904-7005
PregabalinPregabalin 25 mg/1CapsuleOralAmerican Health Packaging60687-473
PregabalinPregabalin 50 mg/1CapsuleOralAmerican Health Packaging60687-484
PregabalinPregabalin 100 mg/1CapsuleOralAmerican Health Packaging60687-506
PregabalinPregabalin 75 mg/1CapsuleOralAmerican Health Packaging60687-495
PregabalinPregabalin 150 mg/1CapsuleOralAmerican Health Packaging60687-517
PregabalinPregabalin 75 mg/1CapsuleOralA-S Medication Solutions50090-6793
PregabalinPregabalin 50 mg/1CapsuleOralBryant Ranch Prepack71335-1300
PregabalinPregabalin 225 mg/1CapsuleOralBryant Ranch Prepack71335-1744
PregabalinPregabalin 50 mg/1CapsuleOralCardinal Health 107, LLC55154-8097
PregabalinPregabalin 75 mg/1CapsuleOralProficient Rx LP71205-298
PregabalinPregabalin 75 mg/1CapsuleOralCardinal Health 107, LLC55154-8098
PregabalinPregabalin 100 mg/1CapsuleOralProficient Rx LP71205-338
PregabalinPregabalin 150 mg/1CapsuleOralBryant Ranch Prepack71335-1459
PregabalinPregabalin 25 mg/1CapsuleOralMajor Pharmaceuticals0904-6991
PregabalinPregabalin 50 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0027
PregabalinPregabalin 225 mg/1CapsuleOralREMEDYREPACK INC.70518-4569
PregabalinPregabalin 100 mg/1CapsuleOralBryant Ranch Prepack71335-1475
PregabalinPregabalin 75 mg/1CapsuleOralBryant Ranch Prepack71335-1476
PregabalinPregabalin 50 mg/1CapsuleOralMajor Pharmaceuticals0904-6992

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