NDC codes

FDA NDC Directory
Product NDC (as listed)47335-711Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0711Add 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
47335-711-084733507110847335071108100 TABLET, FILM COATED in 1 BOTTLE (47335-711-08)Marketed from Dec 15, 2014
47335-711-1847335071118473350711181000 TABLET, FILM COATED in 1 BOTTLE (47335-711-18)Marketed from Dec 15, 2014
47335-711-83473350711834733507118330 TABLET, FILM COATED in 1 BOTTLE (47335-711-83)Marketed from Dec 15, 2014
47335-711-86473350711864733507118660 TABLET, FILM COATED in 1 BOTTLE (47335-711-86)Marketed from Dec 15, 2014
47335-711-884733507118847335071188100 TABLET, FILM COATED in 1 BOTTLE (47335-711-88)Marketed from Dec 15, 2014

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, Film coated
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090278
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 47335-711_532f72d6-a509-0681-e063-6294a90ad4c1SPL ID 532f72d6-a509-0681-e063-6294a90ad4c1SPL set ID 3c909a53-ae66-4b28-a741-b60bb25a69cfRxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391UPC 0347335712865

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

N447335071108 followed by a unit qualifier and the quantity

Package 47335-0711-08. 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 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 Epilepsy Topira…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-711

What is NDC 47335-711?
47335-711 is the product NDC for Topiramate, Topiramate 100 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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
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 278 Topiramate NDCs

Other NDCs under ANDA 090278

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

FDA NDC Directory listings under ANDA 090278
ProductStrengthForm · routeLabelerProduct NDC
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-819
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-998
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-997
TopiramateTopiramate 200 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-712
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-710
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5165
TopiramateTopiramate 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0925
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0325
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-801
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-707
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-004
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0487
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.62756-710
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.62756-707
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.62756-711
TopiramateTopiramate 200 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.62756-712
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-060
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0548
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralProficient Rx LP63187-059
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralProficient Rx LP63187-077

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