NDC codes

FDA NDC Directory
Product NDC (as listed)27241-230Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0230Add 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
27241-230-0127241023001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-01)Marketed from Aug 15, 2023
27241-230-302724102303030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-230-30)Marketed from Aug 15, 2023

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 — 200 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Ajanta Pharma USA Inc.NDC labeler code 27241
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215663
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 27241-230_6a92525c-bf1f-4a48-90a7-62e9baaa553dSPL ID 6a92525c-bf1f-4a48-90a7-62e9baaa553dSPL set ID b94629e3-ae2e-473e-b2f5-06e32ee19aa9RxCUI 1436239, 1437278, 1437283, 1437288UNII 0H73WJJ391UPC 0327241228308, 0327241227301, 0327241230301, 0327241229305

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

N427241023001 followed by a unit qualifier and the quantity

Package 27241-0230-01. 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 extended-release capsules are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome (LGS) in patients 6 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 extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27241-230

What is NDC 27241-230?
27241-230 is the product NDC for Topiramate, Topiramate 200 mg/1 capsule, extended release, listed with the FDA by Ajanta Pharma USA Inc.. It has 2 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?
Ajanta Pharma USA Inc., NDC labeler code 27241. 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 215663

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

FDA NDC Directory listings under ANDA 215663
ProductStrengthForm · routeLabelerProduct NDC
TopiramateTopiramate 25 mg/1Capsule, Extended releaseOralAjanta Pharma USA Inc.27241-227
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralAjanta Pharma USA Inc.27241-228
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralAjanta Pharma USA Inc.27241-229

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