What is NDC 71610-492?

71610-492 is the product NDC for Topiramate, Topiramate 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

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 Topiramate?

277 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topiramate NDC 71610-492 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-492Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0492Add 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 NDC	11-digit (billing)	Package
71610-492-30	7161004923071610049230	30 TABLET in 1 BOTTLE (71610-492-30)Marketed from Nov 17, 2020
71610-492-45	7161004924571610049245	45 TABLET in 1 BOTTLE (71610-492-45)Marketed from Nov 17, 2020
71610-492-53	7161004925371610049253	60 TABLET in 1 BOTTLE (71610-492-53)Marketed from Nov 17, 2020
71610-492-60	7161004926071610049260	90 TABLET in 1 BOTTLE (71610-492-60)Marketed from Nov 17, 2020

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): Topiramate
Generic name (nonproprietary): topiramate
Active ingredients: Topiramate — 100 mg/1
Dosage form: Tablet
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 079162
Marketing start: Sep 7, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 71610-492_875c3303-147e-4bdf-98f2-8355c056e18fSPL ID 875c3303-147e-4bdf-98f2-8355c056e18fSPL set ID 3b18b43c-0de2-4acf-b0d5-f1b601d496deRxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391

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

N471610049230 followed by a unit qualifier and the quantity

Package 71610-0492-30. 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 May 3, 2021.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial- onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adj…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-492

What is NDC 71610-492?: 71610-492 is the product NDC for Topiramate, Topiramate 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topiramate.
What is the active ingredient?: Topiramate.
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 Topiramate?: 277 other product NDCs are listed under this name. See all Topiramate 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 Topiramate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-325	27808-0325-01
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-326	27808-0326-01
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-327	27808-0327-01
Topiramate	Topiramate 150 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-328	27808-0328-01
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-329	27808-0329-01
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-952	60760-0952-60
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0357	67046-0357-03
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1691	67046-1691-03
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-079	87441-0079-01
Topiramate	Topiramate 100 mg/1	TabletOral	Coupler LLC	67046-1688	67046-1688-03

All 278 Topiramate NDCs

Other NDCs under ANDA 079162

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

FDA NDC Directory listings under ANDA 079162
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 50 mg/1	TabletOral	Proficient Rx LP	63187-228
Topiramate	Topiramate 25 mg/1	TabletOral	Cipla USA Inc.	69097-816
Topiramate	Topiramate 50 mg/1	TabletOral	Cipla USA Inc.	69097-817
Topiramate	Topiramate 100 mg/1	TabletOral	Cipla USA Inc.	69097-818
Topiramate	Topiramate 200 mg/1	TabletOral	Cipla USA Inc.	69097-819
Topiramate	Topiramate 25 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-485
Topiramate	Topiramate 50 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-486
Topiramate	Topiramate 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-493
Topiramate	Topiramate 25 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-278
Topiramate	Topiramate 50 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-279
Topiramate	Topiramate 100 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-280
Topiramate	Topiramate 200 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-281