NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1691Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1691Add 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
67046-1691-36704616910330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1691-3)Marketed from Aug 3, 2026

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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090162
Marketing start
Listing expires
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 67046-1691_5826ca76-89b5-72b1-e063-6294a90a8468SPL ID 5826ca76-89b5-72b1-e063-6294a90a8468SPL set ID 5826cb22-3559-171b-e063-6394a90ad594RxCUI 199889UNII 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

N467046169103 followed by a unit qualifier and the quantity

Package 67046-1691-03. 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 .

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 Epi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1691

What is NDC 67046-1691?
67046-1691 is the product NDC for topiramate, Topiramate 100 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?
Coupler LLC, NDC labeler code 67046. 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?
278 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
topiramateTopiramate 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-95260760-0952-60
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-035767046-0357-03
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07987441-0079-01
TopiramateTopiramate 100 mg/1TabletOralCoupler LLC67046-168867046-1688-03
topiramateTopiramate 25 mg/1Tablet, Film coatedOralCoupler LLC67046-037567046-0375-03
topiramateTopiramate 200 mg/1Tablet, Film coatedOralAvPAK50268-80950268-0809-15
topiramateTopiramate 25 mg/1Tablet, Film coatedOralAvPAK50268-80650268-0806-15
topiramateTopiramate 50 mg/1Tablet, Film coatedOralAvPAK50268-80750268-0807-15
topiramateTopiramate 100 mg/1Tablet, Film coatedOralAvPAK50268-80850268-0808-15
topiramateTopiramate 25 mg/1Tablet, Film coatedOralCoupler LLC67046-118067046-1180-03

All 279 topiramate NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
topiramateTopiramate 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2203
topiramateTopiramate 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1064
topiramateTopiramate 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2102
topiramateTopiramate 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4760
topiramateTopiramate 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7757
topiramateTopiramate 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-187
topiramateTopiramate 100 mg/1Tablet, Film coatedOralProficient Rx LP71205-195
topiramateTopiramate 25 mg/1Tablet, Film coatedOralProficient Rx LP71205-202
topiramateTopiramate 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-952
topiramateTopiramate 25 mg/1Tablet, Film coatedOralCoupler LLC67046-1180
topiramateTopiramate 50 mg/1Tablet, Film coatedOralCoupler LLC67046-1202
topiramateTopiramate 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9727
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0214
topiramateTopiramate 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2318
topiramateTopiramate 200 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4067
topiramateTopiramate 100 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0488
topiramateTopiramate 50 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0495
topiramateTopiramate 100 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-117
topiramateTopiramate 25 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-115
topiramateTopiramate 50 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-116

Showing 20 of 34.

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