NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1789Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1789Add 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
71335-1789-1713351789017133517890130 CAPSULE in 1 BOTTLE (71335-1789-1)Marketed from Mar 10, 2021
71335-1789-2713351789027133517890290 CAPSULE in 1 BOTTLE (71335-1789-2)Marketed from Mar 8, 2021
71335-1789-3713351789037133517890360 CAPSULE in 1 BOTTLE (71335-1789-3)Marketed from Mar 11, 2021

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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206912
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 71335-1789_509a0a9e-1158-48c0-bb8c-c2ece3a3cc4aSPL ID 509a0a9e-1158-48c0-bb8c-c2ece3a3cc4aSPL set ID aac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1RxCUI 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

N471335178901 followed by a unit qualifier and the quantity

Package 71335-1789-01. 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 71335-1789

What is NDC 71335-1789?
71335-1789 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 206912

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

FDA NDC Directory listings under ANDA 206912
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 75 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0147
PregabalinPregabalin 50 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8472
PregabalinPregabalin 50 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0152
PregabalinPregabalin 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0170
PregabalinPregabalin 150 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0178
PregabalinPregabalin 200 mg/1CapsuleOralA-S Medication Solutions50090-7983
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-4715
PregabalinPregabalin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-4716
PregabalinPregabalin 50 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-611
PregabalinPregabalin 25 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-610
PregabalinPregabalin 200 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-615
PregabalinPregabalin 75 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-612
PregabalinPregabalin 100 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-613
PregabalinPregabalin 150 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-614
PregabalinPregabalin 225 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-616
PregabalinPregabalin 300 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-617
PregabalinPregabalin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-4743
PregabalinPregabalin 25 mg/1CapsuleOralREMEDYREPACK INC.70518-4272
PregabalinPregabalin 200 mg/1CapsuleOralREMEDYREPACK INC.70518-4749
PregabalinPregabalin 50 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-768

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