NDC codes

FDA NDC Directory
Product NDC (as listed)65862-761Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0761Add 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
65862-761-016586207610165862076101100 CAPSULE in 1 BOTTLE (65862-761-01)Marketed from Mar 29, 2023
65862-761-056586207610565862076105500 CAPSULE in 1 BOTTLE (65862-761-05)Marketed from Mar 29, 2023
65862-761-78658620761786586207617810 BLISTER PACK in 1 CARTON (65862-761-78) / 10 CAPSULE in 1 BLISTER PACK (65862-761-10)Marketed from Mar 29, 2023
65862-761-90658620761906586207619090 CAPSULE in 1 BOTTLE (65862-761-90)Marketed from Mar 29, 2023

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
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205321
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 65862-761_03c24a38-f80a-4acb-ab38-c747c13125d4SPL ID 03c24a38-f80a-4acb-ab38-c747c13125d4SPL set ID 11034861-eef2-4996-8082-afc3c1769171RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0365862758903

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

N465862076101 followed by a unit qualifier and the quantity

Package 65862-0761-01. 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 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 65862-761

What is NDC 65862-761?
65862-761 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Aurobindo Pharma 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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 205321

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

FDA NDC Directory listings under ANDA 205321
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 25 mg/1CapsuleOralCoupler LLC67046-1680
PregabalinPregabalin 50 mg/1CapsuleOralCoupler LLC67046-1494
PregabalinPregabalin 75 mg/1CapsuleOralAurobindo Pharma Limited65862-760
PregabalinPregabalin 25 mg/1CapsuleOralAurobindo Pharma Limited65862-758
PregabalinPregabalin 50 mg/1CapsuleOralAurobindo Pharma Limited65862-759
PregabalinPregabalin 200 mg/1CapsuleOralAurobindo Pharma Limited65862-763
PregabalinPregabalin 150 mg/1CapsuleOralAurobindo Pharma Limited65862-762
PregabalinPregabalin 225 mg/1CapsuleOralAurobindo Pharma Limited65862-764
PregabalinPregabalin 300 mg/1CapsuleOralAurobindo Pharma Limited65862-765
PregabalinPregabalin 25 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0758
PregabalinPregabalin 50 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0759
PregabalinPregabalin 200 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0763
PregabalinPregabalin 75 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0760
PregabalinPregabalin 100 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0761
PregabalinPregabalin 150 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0762
PregabalinPregabalin 225 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0764
PregabalinPregabalin 300 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-0765
PregabalinPregabalin 100 mg/1CapsuleOralCoupler LLC67046-1628
PregabalinPregabalin 100 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-871

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