NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3974Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3974Add 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
70518-3974-0705183974007051839740030 CAPSULE in 1 BLISTER PACK (70518-3974-0)Marketed from Jan 3, 2024

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 — 25 mg/1
Dosage form
Capsule
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209743
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 70518-3974_5980592d-8218-1bcb-e063-6294a90af068SPL ID 5980592d-8218-1bcb-e063-6294a90af068SPL set ID d095accf-9cea-4948-b43d-ae1b8fbce7c2RxCUI 483442UNII 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

N470518397400 followed by a unit qualifier and the quantity

Package 70518-3974-00. 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 70518-3974

What is NDC 70518-3974?
70518-3974 is the product NDC for Pregabalin, Pregabalin 25 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 209743

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

FDA NDC Directory listings under ANDA 209743
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 25 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1310
PregabalinPregabalin 50 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1311
PregabalinPregabalin 75 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1312
PregabalinPregabalin 100 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1313
PregabalinPregabalin 150 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1314
PregabalinPregabalin 200 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1315
PregabalinPregabalin 225 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1316
PregabalinPregabalin 300 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1317
PregabalinPregabalin 25 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1310
PregabalinPregabalin 50 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1311
PregabalinPregabalin 75 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1312
PregabalinPregabalin 100 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1313
PregabalinPregabalin 150 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1314
PregabalinPregabalin 200 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1315
PregabalinPregabalin 225 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1316
PregabalinPregabalin 300 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1317
PregabalinPregabalin 75 mg/1CapsuleOralProficient Rx LP71205-816
PregabalinPregabalin 100 mg/1CapsuleOralDirect_Rx72189-033
PregabalinPregabalin 225 mg/1CapsuleOralDirect_Rx72189-045
PregabalinPregabalin 25 mg/1CapsuleOralDirect_Rx72189-115

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