NDC codes

FDA NDC Directory
Product NDC (as listed)25000-183Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25000-0183Add 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
25000-183-072500001830790 CAPSULE in 1 BOTTLE (25000-183-07)Marketed from Aug 1, 2022

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 — 150 mg/1
Dosage form
Capsule
Route
Oral
Labeler
MARKSANS PHARMA LIMITEDNDC labeler code 25000
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216197
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 25000-183_b8d46cc7-2959-411f-839c-eced90c38e92SPL ID b8d46cc7-2959-411f-839c-eced90c38e92SPL set ID b2b81bb6-5423-4221-8a61-f70a38d6a1e9RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 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

N425000018307 followed by a unit qualifier and the quantity

Package 25000-0183-07. 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: 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) 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 25000-183

What is NDC 25000-183?
25000-183 is the product NDC for Pregabalin, Pregabalin 150 mg/1 capsule, listed with the FDA by MARKSANS PHARMA LIMITED. 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?
MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 300 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44629300-0446-19
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-471570518-4715-00
PregabalinPregabalin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-471670518-4716-00
PregabalinPregabalin 225 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44529300-0445-19
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 216197

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

FDA NDC Directory listings under ANDA 216197
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 50 mg/1CapsuleOralMARKSANS PHARMA LIMITED25000-180
PregabalinPregabalin 25 mg/1CapsuleOralMARKSANS PHARMA LIMITED25000-179
PregabalinPregabalin 200 mg/1CapsuleOralMARKSANS PHARMA LIMITED25000-184
PregabalinPregabalin 75 mg/1CapsuleOralMARKSANS PHARMA LIMITED25000-181
PregabalinPregabalin 100 mg/1CapsuleOralMARKSANS PHARMA LIMITED25000-182
PregabalinPregabalin 225 mg/1CapsuleOralMARKSANS PHARMA LIMITED25000-185
PregabalinPregabalin 300 mg/1CapsuleOralMARKSANS PHARMA LIMITED25000-186

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Pregabalin NDC 25000-183 | National Drug Code | Med-Code