NDC codes

FDA NDC Directory
Product NDC (as listed)71610-317Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0317Add 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
71610-317-307161003173030 CAPSULE in 1 BOTTLE (71610-317-30)Marketed from Aug 12, 2019
71610-317-467161003174656 CAPSULE in 1 BOTTLE (71610-317-46)Marketed from Aug 12, 2019
71610-317-537161003175360 CAPSULE in 1 BOTTLE (71610-317-53)Marketed from Aug 12, 2019
71610-317-547161003175484 CAPSULE in 1 BOTTLE (71610-317-54)Marketed from Nov 28, 2023
71610-317-7071610031770120 CAPSULE in 1 BOTTLE (71610-317-70)Marketed from Aug 12, 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 — 150 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211384
Marketing start
Listing expires
DEA schedule
CV
Identifiers
Product ID 71610-317_9d6ac8b5-77e4-4c4f-9c24-8d3043149146SPL ID 9d6ac8b5-77e4-4c4f-9c24-8d3043149146SPL set ID bf710bcf-75ed-4184-b9c3-81cd05a780a4RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 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

N471610031730 followed by a unit qualifier and the quantity

Package 71610-0317-30. 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. Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-317

What is NDC 71610-317?
71610-317 is the product NDC for Pregabalin, Pregabalin 150 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 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?
Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 75 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44129300-0441-19
PregabalinPregabalin 25 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-43929300-0439-19
PregabalinPregabalin 50 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44029300-0440-19
PregabalinPregabalin 300 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44629300-0446-19
PregabalinPregabalin 75 mg/1CapsuleOralREMEDYREPACK INC.70518-471570518-4715-00
PregabalinPregabalin 300 mg/1CapsuleOralREMEDYREPACK INC.70518-471670518-4716-00
PregabalinPregabalin 225 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44529300-0445-19
PregabalinPregabalin 100 mg/1CapsuleOralUnichem Pharmaceuticals (USA), Inc.29300-44229300-0442-19

All 510 Pregabalin NDCs

Other NDCs under ANDA 211384

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

FDA NDC Directory listings under ANDA 211384
ProductStrengthForm · routeLabelerProduct NDC
PregabalinPregabalin 75 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-765
PregabalinPregabalin 25 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-568
PregabalinPregabalin 50 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-569
PregabalinPregabalin 75 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-570
PregabalinPregabalin 100 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-571
PregabalinPregabalin 150 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-572
PregabalinPregabalin 200 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-573
PregabalinPregabalin 225 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-574
PregabalinPregabalin 300 mg/1CapsuleOralExelan Pharmaceuticals Inc.76282-575
PregabalinPregabalin 25 mg/1CapsuleOralCipla USA, Inc.69097-954
PregabalinPregabalin 25 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-313
PregabalinPregabalin 50 mg/1CapsuleOralCipla USA, Inc.69097-955
PregabalinPregabalin 50 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-314
PregabalinPregabalin 75 mg/1CapsuleOralCipla USA, Inc.69097-956
PregabalinPregabalin 100 mg/1CapsuleOralCipla USA, Inc.69097-957
PregabalinPregabalin 100 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-316
PregabalinPregabalin 150 mg/1CapsuleOralCipla USA, Inc.69097-958
PregabalinPregabalin 200 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-318
PregabalinPregabalin 200 mg/1CapsuleOralCipla USA, Inc.69097-959
PregabalinPregabalin 225 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-319

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