topiramate NDC 68788-8817

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8817Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8817Add 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
68788-8817-3	68788881703	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-3)Marketed from Jan 21, 2025
68788-8817-5	68788881705	15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-5)Marketed from Jan 21, 2025
68788-8817-6	68788881706	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-6)Marketed from Jan 21, 2025
68788-8817-8	68788881708	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-8)Marketed from Jan 21, 2025
68788-8817-9	68788881709	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8817-9)Marketed from Jan 21, 2025

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): topiramate
Generic name (nonproprietary): topiramate
Active ingredients: Topiramate — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090162
Marketing start: Jan 21, 2025
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 68788-8817_521be3f1-3ee7-45c7-9f0c-17e08b6c8fcaSPL ID 521be3f1-3ee7-45c7-9f0c-17e08b6c8fcaSPL set ID 521be3f1-3ee7-45c7-9f0c-17e08b6c8fcaRxCUI 199888UNII 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

N468788881703 followed by a unit qualifier and the quantity

Package 68788-8817-03. 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 Jan 21, 2025.

Indications (excerpt from the label)

Topiramate tablets are 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 Adjunctive Therapy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090162

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

FDA NDC Directory listings under ANDA 090162
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0214
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2481
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7067
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2480
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-117
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-115
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-116
topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-118
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0488
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-752
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8828
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0495
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4515
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8835
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3660
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1064
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2102
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4760
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0288
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2203

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