NDC codes

FDA NDC Directory
Product NDC (as listed)64980-417Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0417Add 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
64980-417-016498004170110 BLISTER PACK in 1 CARTON (64980-417-01) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jul 19, 2019
64980-417-096498004170990 CAPSULE in 1 BOTTLE (64980-417-09)Marketed from Jul 19, 2019
64980-417-10649800417101000 CAPSULE in 1 BOTTLE (64980-417-10)Marketed from Jul 19, 2019

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
Rising Pharma Holdings, Inc.NDC labeler code 64980
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 64980-417_ed8357e8-6f9d-4b09-b3f0-48417fe7f481SPL ID ed8357e8-6f9d-4b09-b3f0-48417fe7f481SPL set ID dbebfa61-0685-41b4-8364-00b8d8b73714RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0364980413107, 0364980411103, 0364980415101, 0364980412100, 0364980416108, 0364980414104, 0364980410106, 0364980417105

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

N464980041701 followed by a unit qualifier and the quantity

Package 64980-0417-01. 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 64980-417

What is NDC 64980-417?
64980-417 is the product NDC for Pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 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 100 mg/1CapsuleOralMajor Pharmaceuticals0904-7001
PregabalinPregabalin 300 mg/1CapsuleOralBryant Ranch Prepack71335-1505
PregabalinPregabalin 150 mg/1CapsuleOralMajor Pharmaceuticals0904-7002
PregabalinPregabalin 200 mg/1CapsuleOralMajor Pharmaceuticals0904-7003
PregabalinPregabalin 225 mg/1CapsuleOralMajor Pharmaceuticals0904-7004
PregabalinPregabalin 100 mg/1CapsuleOralAsclemed USA, Inc.76420-120
PregabalinPregabalin 25 mg/1CapsuleOralAsclemed USA, Inc.76420-117
PregabalinPregabalin 50 mg/1CapsuleOralAsclemed USA, Inc.76420-118
PregabalinPregabalin 75 mg/1CapsuleOralAsclemed USA, Inc.76420-119
PregabalinPregabalin 300 mg/1CapsuleOralMajor Pharmaceuticals0904-7005
PregabalinPregabalin 300 mg/1CapsuleOralAsclemed USA, Inc.76420-124
PregabalinPregabalin 150 mg/1CapsuleOralAsclemed USA, Inc.76420-121
PregabalinPregabalin 200 mg/1CapsuleOralAsclemed USA, Inc.76420-122
PregabalinPregabalin 225 mg/1CapsuleOralAsclemed USA, Inc.76420-123
PregabalinPregabalin 150 mg/1CapsuleOralBryant Ranch Prepack72162-2304
PregabalinPregabalin 25 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-410
PregabalinPregabalin 50 mg/1CapsuleOralQuality Care Products, LLC55700-774
PregabalinPregabalin 150 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-414
PregabalinPregabalin 50 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-411
PregabalinPregabalin 75 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-412

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