NDC codes

FDA NDC Directory
Product NDC (as listed)71205-214Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0214Add 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
71205-214-30712050214307120502143030 TABLET, FILM COATED in 1 BOTTLE (71205-214-30)Marketed from Feb 1, 2019
71205-214-60712050214607120502146060 TABLET, FILM COATED in 1 BOTTLE (71205-214-60)Marketed from Feb 1, 2019
71205-214-90712050214907120502149090 TABLET, FILM COATED in 1 BOTTLE (71205-214-90)Marketed from Feb 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 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 71205-214_79e1cc8f-0005-4913-8ac2-8a9b1d73e171SPL ID 79e1cc8f-0005-4913-8ac2-8a9b1d73e171SPL set ID e382a731-ef73-4990-bc74-ffc3a91ff3baRxCUI 199888UNII 0H73WJJ391UPC 0371205214906

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

N471205021430 followed by a unit qualifier and the quantity

Package 71205-0214-30. 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 in patients ≥2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2) • Prophylaxis of migraine in patients 12 years of age and older (1.3) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. 1.2 Adjunctive Therapy Epilepsy Topiramate t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-214

What is NDC 71205-214?
71205-214 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?
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 100 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-711
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

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