NDC codes

FDA NDC Directory
Product NDC (as listed)27808-237Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27808-0237Add 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
27808-237-012780802370190 CAPSULE in 1 BOTTLE (27808-237-01)Marketed from Feb 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 — 100 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214322
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 27808-237_34723420-dabe-4070-83f1-5de1db603532SPL ID 34723420-dabe-4070-83f1-5de1db603532SPL set ID 62aa850d-199c-44d5-a730-45f43efa850eRxCUI 483438, 483440, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0327808239013, 0327808237019, 0327808241016, 0327808236012, 0327808240019, 0327808235015, 0327808238016

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

N427808023701 followed by a unit qualifier and the quantity

Package 27808-0237-01. 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 is 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)

Other NDCs under ANDA 214322

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

FDA NDC Directory listings under ANDA 214322
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 300 mg/1CapsuleOralTris Pharma Inc27808-241
PregabalinPregabalin 50 mg/1CapsuleOralTris Pharma Inc27808-235
PregabalinPregabalin 75 mg/1CapsuleOralTris Pharma Inc27808-236
PregabalinPregabalin 225 mg/1CapsuleOralTris Pharma Inc27808-240
PregabalinPregabalin 150 mg/1CapsuleOralTris Pharma Inc27808-238
PregabalinPregabalin 200 mg/1CapsuleOralTris Pharma Inc27808-239

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