What is NDC 69097-816?

69097-816 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-816 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-816Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0816Add 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
69097-816-03	6909708160369097081603	60 TABLET in 1 BOTTLE (69097-816-03)Marketed from Jul 22, 2016
69097-816-12	6909708161269097081612	500 TABLET in 1 BOTTLE (69097-816-12)Marketed from Jul 22, 2016
69097-816-15	6909708161569097081615	1000 TABLET in 1 BOTTLE (69097-816-15)Marketed from Jul 22, 2016

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 — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079162
Marketing start: Jul 22, 2016
Listing expires: Dec 31, 2027
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 69097-816_1b47473e-6644-4026-90e5-b169fce62b60SPL ID 1b47473e-6644-4026-90e5-b169fce62b60SPL set ID 4087eb3c-96e9-4d0a-b80b-663e1c86d256RxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391UPC 0369097817039, 0369097818036, 0369097816032, 0369097819033

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

N469097081603 followed by a unit qualifier and the quantity

Package 69097-0816-03. 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 Apr 14, 2025.

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 69097-816

What is NDC 69097-816?: 69097-816 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 3 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?: Cipla USA Inc., NDC labeler code 69097. 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 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 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-492
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