NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8360Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8360Add 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
68788-8360-168788836001100 CAPSULE in 1 BLISTER PACK (68788-8360-1)Marketed from Feb 1, 2023
68788-8360-36878883600330 CAPSULE in 1 BOTTLE (68788-8360-3)Marketed from Feb 1, 2023
68788-8360-66878883600660 CAPSULE in 1 BOTTLE (68788-8360-6)Marketed from Feb 1, 2023
68788-8360-96878883600990 CAPSULE in 1 BOTTLE (68788-8360-9)Marketed from Feb 1, 2023

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 — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207799
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 68788-8360_582d8992-18e4-4886-bc7d-d668fa763e44SPL ID 582d8992-18e4-4886-bc7d-d668fa763e44SPL set ID e8e272a4-c181-4573-822b-2bb315b6ad37RxCUI 483438UNII 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

N468788836001 followed by a unit qualifier and the quantity

Package 68788-8360-01. 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 is 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)

About NDC 68788-8360

What is NDC 68788-8360?
68788-8360 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 300 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44629300-0446-19
PregabalinPregabalin 150 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44329300-0443-19
PregabalinPregabalin 200 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44429300-0444-19
PregabalinPregabalin 225 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44529300-0445-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 207799

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

FDA NDC Directory listings under ANDA 207799
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 25 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1462
PregabalinPregabalin 150 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1466
PregabalinPregabalin 50 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1463
PregabalinPregabalin 75 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1464
PregabalinPregabalin 100 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1465
PregabalinPregabalin 200 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1467
PregabalinPregabalin 75 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0417
PregabalinPregabalin 300 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0160
PregabalinPregabalin 50 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0421
PregabalinPregabalin 150 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0185
PregabalinPregabalin 75 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8391
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-3597
PregabalinPregabalin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-3643
PregabalinPregabalin 50 mg/1CapsuleOralREMEDYREPACK INC.70518-3636
PregabalinPregabalin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-3647
PregabalinPregabalin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-3646
PregabalinPregabalin 100 mg/1CapsuleOralBryant Ranch Prepack71335-1740
PregabalinPregabalin 150 mg/1CapsuleOralBryant Ranch Prepack71335-1745
PregabalinPregabalin 50 mg/1CapsuleOralBryant Ranch Prepack71335-1751
PregabalinPregabalin 75 mg/1CapsuleOralBryant Ranch Prepack71335-1758

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