NDC codes

FDA NDC Directory
Product NDC (as listed)72189-021Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0021Add 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
72189-021-30721890021307218900213030 CAPSULE in 1 BOTTLE (72189-021-30)Marketed from Jul 30, 2019
72189-021-60721890021607218900216060 CAPSULE in 1 BOTTLE (72189-021-60)Marketed from Jul 30, 2019
72189-021-90721890021907218900219090 CAPSULE in 1 BOTTLE (72189-021-90)Marketed from Jul 30, 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 — 75 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Direct_RxNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208677
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 72189-021_2c4e8635-a2d3-601d-e063-6294a90aaee3SPL ID 2c4e8635-a2d3-601d-e063-6294a90aaee3SPL set ID 8ee9e08f-cf87-599c-e053-2995a90a563cRxCUI 483450UNII 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

N472189002130 followed by a unit qualifier and the quantity

Package 72189-0021-30. 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 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-021

What is NDC 72189-021?
72189-021 is the product NDC for Pregabalin, Pregabalin 75 mg/1 capsule, listed with the FDA by Direct_Rx. 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?
Direct_Rx, NDC labeler code 72189. 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 150 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44329300-0443-19
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

All 510 Pregabalin NDCs

Other NDCs under ANDA 208677

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

FDA NDC Directory listings under ANDA 208677
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 50 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-930
PregabalinPregabalin 25 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-931
PregabalinPregabalin 225 mg/1CapsuleOralBryant Ranch Prepack63629-8239
PregabalinPregabalin 100 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-894
PregabalinPregabalin 300 mg/1CapsuleOralScieGen Pharmaceuticals, Inc50228-652
PregabalinPregabalin 300 mg/1CapsuleOralBryant Ranch Prepack63629-8248
PregabalinPregabalin 50 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC53401-007
PregabalinPregabalin 200 mg/1CapsuleOralDirect_Rx72189-241
PregabalinPregabalin 200 mg/1CapsuleOralQuality Care Products, LLC55700-964
PregabalinPregabalin 75 mg/1CapsuleOralBryant Ranch Prepack72162-1543
PregabalinPregabalin 25 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0433
PregabalinPregabalin 25 mg/1CapsuleOralBryant Ranch Prepack72162-1541
PregabalinPregabalin 50 mg/1CapsuleOralBryant Ranch Prepack72162-1542
PregabalinPregabalin 100 mg/1CapsuleOralBryant Ranch Prepack72162-1544
PregabalinPregabalin 300 mg/1CapsuleOralDirect_Rx72189-251
PregabalinPregabalin 300 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0177
PregabalinPregabalin 150 mg/1CapsuleOralBryant Ranch Prepack72162-1545
PregabalinPregabalin 200 mg/1CapsuleOralBryant Ranch Prepack72162-1546
PregabalinPregabalin 100 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-577
PregabalinPregabalin 225 mg/1CapsuleOralBryant Ranch Prepack72162-1547

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