NDC codes

FDA NDC Directory
Product NDC (as listed)46708-124Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0124Add 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
46708-124-104670801241046708012410100 CAPSULE in 1 CARTON (46708-124-10)Marketed from Jul 19, 2019
46708-124-30467080124304670801243030 CAPSULE in 1 BOTTLE (46708-124-30)Marketed from Jul 19, 2019
46708-124-90467080124904670801249090 CAPSULE in 1 BOTTLE (46708-124-90)Marketed from Jul 19, 2019
46708-124-9146708012491467080124911000 CAPSULE in 1 BOTTLE (46708-124-91)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 — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203459
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 46708-124_b746d2ae-57e4-4a36-9524-35c4aa6b4ef2SPL ID b746d2ae-57e4-4a36-9524-35c4aa6b4ef2SPL set ID 78a36538-701d-4dd9-a7fc-87d505784c83RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0346708126308, 0346708122300, 0346708125301

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

N446708012410 followed by a unit qualifier and the quantity

Package 46708-0124-10. 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 capsule is 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 17 years of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin capsule is indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) • …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-124

What is NDC 46708-124?
46708-124 is the product NDC for Pregabalin, Pregabalin 200 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 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?
Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 203459

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203459
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 25 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-119
PregabalinPregabalin 50 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-120
PregabalinPregabalin 75 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-121
PregabalinPregabalin 100 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-122
PregabalinPregabalin 150 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-123
PregabalinPregabalin 225 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-125
PregabalinPregabalin 300 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-126
PregabalinPregabalin 25 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-119
PregabalinPregabalin 50 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-120
PregabalinPregabalin 75 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-121
PregabalinPregabalin 100 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-122
PregabalinPregabalin 150 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-123
PregabalinPregabalin 200 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-124
PregabalinPregabalin 225 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-125
PregabalinPregabalin 300 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-126

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