NDC codes

FDA NDC Directory
Product NDC (as listed)51407-893Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0893Add 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
51407-893-605140708936060 CAPSULE in 1 BOTTLE, PLASTIC (51407-893-60)Marketed from Mar 19, 2024

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
Topiramate15 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217694
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 51407-893_55069b30-2f93-2d4f-e063-6294a90ae7a6SPL ID 55069b30-2f93-2d4f-e063-6294a90ae7a6SPL set ID 163e9f2d-27be-6d3f-e063-6394a90a5884RxCUI 205315, 205316UNII 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

N451407089360 followed by a unit qualifier and the quantity

Package 51407-0893-60. 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 capsules 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 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 Adjunctive Therapy Epile

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217694

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

FDA NDC Directory listings under ANDA 217694
ProductStrengthForm · routeLabelerProduct NDC
TopiramateTopiramate 15 mg/1CapsuleOralUpsher-Smith Laboratories, LLC24979-210
TopiramateTopiramate 25 mg/1CapsuleOralUpsher-Smith Laboratories, LLC24979-211
TopiramateTopiramate 25 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-894

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