NDC codes

FDA NDC Directory
Product NDC (as listed)51655-608Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51655-0608Add 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
51655-608-26516550608265165506082690 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-608-26)Marketed from Feb 2, 2015
51655-608-52516550608525165506085230 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-608-52)Marketed from Feb 2, 2015

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
Northwind Health Company, LLCNDC labeler code 51655
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077627
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 51655-608_4b809f46-07c3-68fd-e063-6394a90a3fabSPL ID 4b809f46-07c3-68fd-e063-6394a90a3fabSPL set ID ae63e0e2-ceb1-4cc7-88fa-92cfa4516960RxCUI 199889UNII 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

N451655060826 followed by a unit qualifier and the quantity

Package 51655-0608-26. 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 tablets 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 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 E…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51655-608

What is NDC 51655-608?
51655-608 is the product NDC for Topiramate, Topiramate 100 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. 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?
Northwind Health Company, LLC, NDC labeler code 51655. 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 077627

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

FDA NDC Directory listings under ANDA 077627
ProductStrengthForm · routeLabelerProduct NDC
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2955
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-079
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-283
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-108
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-109
TopiramateTopiramate 200 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-110
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-153
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4340
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralProficient Rx LP63187-479
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralProficient Rx LP63187-118

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