NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1505Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1505Add 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
71335-1505-1713351505017133515050160 CAPSULE in 1 BOTTLE (71335-1505-1)Marketed from Feb 19, 2020
71335-1505-2713351505027133515050290 CAPSULE in 1 BOTTLE (71335-1505-2)Marketed from Sep 20, 2022
71335-1505-3713351505037133515050330 CAPSULE in 1 BOTTLE (71335-1505-3)Marketed from Sep 20, 2022

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 — 300 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-1505_ef869518-e222-4dab-a77b-820fec1ce911SPL ID ef869518-e222-4dab-a77b-820fec1ce911SPL set ID 15b5e3d0-2bad-4363-99cb-e15819c41fdaRxCUI 483444UNII 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

N471335150501 followed by a unit qualifier and the quantity

Package 71335-1505-01. 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 71335-1505

What is NDC 71335-1505?
71335-1505 is the product NDC for Pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 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 25 mg/1CapsuleOralMajor Pharmaceuticals0904-6991
PregabalinPregabalin 50 mg/1CapsuleOralMajor Pharmaceuticals0904-6992
PregabalinPregabalin 75 mg/1CapsuleOralMajor Pharmaceuticals0904-7000
PregabalinPregabalin 100 mg/1CapsuleOralMajor Pharmaceuticals0904-7001
PregabalinPregabalin 150 mg/1CapsuleOralMajor Pharmaceuticals0904-7002
PregabalinPregabalin 200 mg/1CapsuleOralMajor Pharmaceuticals0904-7003
PregabalinPregabalin 225 mg/1CapsuleOralMajor Pharmaceuticals0904-7004
PregabalinPregabalin 300 mg/1CapsuleOralMajor Pharmaceuticals0904-7005
PregabalinPregabalin 75 mg/1CapsuleOralA-S Medication Solutions50090-6793
PregabalinPregabalin 100 mg/1CapsuleOralCardinal Health 107, LLC55154-4308
PregabalinPregabalin 50 mg/1CapsuleOralCardinal Health 107, LLC55154-8097
PregabalinPregabalin 75 mg/1CapsuleOralCardinal Health 107, LLC55154-8098
PregabalinPregabalin 100 mg/1CapsuleOralQuality Care Products, LLC55700-773
PregabalinPregabalin 50 mg/1CapsuleOralQuality Care Products, LLC55700-774
PregabalinPregabalin 75 mg/1CapsuleOralQuality Care Products, LLC55700-775
PregabalinPregabalin 25 mg/1CapsuleOralAmerican Health Packaging60687-473
PregabalinPregabalin 50 mg/1CapsuleOralAmerican Health Packaging60687-484
PregabalinPregabalin 75 mg/1CapsuleOralAmerican Health Packaging60687-495
PregabalinPregabalin 100 mg/1CapsuleOralAmerican Health Packaging60687-506
PregabalinPregabalin 150 mg/1CapsuleOralAmerican Health Packaging60687-517

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