NDC codes

FDA NDC Directory
Product NDC (as listed)71205-233Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0233Add 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
71205-233-307120502333030 TABLET, FILM COATED in 1 BOTTLE (71205-233-30)Marketed from Jun 1, 2019
71205-233-607120502336060 TABLET, FILM COATED in 1 BOTTLE (71205-233-60)Marketed from Jun 1, 2019
71205-233-907120502339090 TABLET, FILM COATED in 1 BOTTLE (71205-233-90)Marketed from Jun 1, 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)
topiramate
Generic name (nonproprietary)
topiramate
Active ingredients
Topiramate — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078235
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 71205-233_e394ff4b-4fb0-418c-866f-3e5d95461bfaSPL ID e394ff4b-4fb0-418c-866f-3e5d95461bfaSPL set ID 80481455-7ad7-4f44-8113-b8b61d8581a0RxCUI 199888UNII 0H73WJJ391UPC 0371205233600

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

N471205023330 followed by a unit qualifier and the quantity

Package 71205-0233-30. 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)

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 and topiramate capsules 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 A…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-233

What is NDC 71205-233?
71205-233 is the product NDC for topiramate, Topiramate 25 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 71205. 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?
276 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 25 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32527808-0325-01
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32627808-0326-01
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32727808-0327-01
TopiramateTopiramate 150 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32827808-0328-01
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32927808-0329-01
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 100 mg/1Tablet, Film coatedOralCoupler LLC67046-169167046-1691-03
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07987441-0079-01
TopiramateTopiramate 100 mg/1TabletOralCoupler LLC67046-168867046-1688-03

All 277 topiramate NDCs

Other NDCs under ANDA 078235

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

FDA NDC Directory listings under ANDA 078235
ProductStrengthForm · routeLabelerProduct NDC
topiramateTopiramate 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6928
topiramateTopiramate 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6929
topiramateTopiramate 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5309
topiramateTopiramate 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5853
topiramateTopiramate 25 mg/1Tablet, Film coatedOralAvPAK50268-806
topiramateTopiramate 50 mg/1Tablet, Film coatedOralAvPAK50268-807
topiramateTopiramate 100 mg/1Tablet, Film coatedOralAvPAK50268-808
topiramateTopiramate 200 mg/1Tablet, Film coatedOralAvPAK50268-809
topiramateTopiramate 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-429
topiramateTopiramate 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-746
topiramateTopiramate 100 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-848
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7142
topiramateTopiramate 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7146
topiramateTopiramate 25 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-075
topiramateTopiramate 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-577
topiramateTopiramate 25 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-647
topiramateTopiramate 50 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-648
topiramateTopiramate 100 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-649
topiramateTopiramate 200 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-650
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-0357

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