NDC codes

FDA NDC Directory
Product NDC (as listed)55154-7146Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-7146Add 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
55154-7146-0551547146005515471460010 BLISTER PACK in 1 BAG (55154-7146-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 1, 2012

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Cardinal Health 107, LLCNDC labeler code 55154
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078235
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 55154-7146_2d46744a-7592-48f3-afd3-a2b9c0cdcfdbSPL ID 2d46744a-7592-48f3-afd3-a2b9c0cdcfdb

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

N455154714600 followed by a unit qualifier and the quantity

Package 55154-7146-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 55154-7146

What is NDC 55154-7146?
55154-7146 is the product NDC for topiramate, Topiramate 25 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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 078235

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

FDA NDC Directory listings under ANDA 078235
ProductStrengthForm · routeLabelerProduct NDC
topiramateTopiramate 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6928
topiramateTopiramate 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6929
topiramateTopiramate 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3926
topiramateTopiramate 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5309
topiramateTopiramate 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5853
topiramateTopiramate 25 mg/1Tablet, Film coatedOralAvPAK50268-806
topiramateTopiramate 50 mg/1Tablet, Film coatedOralAvPAK50268-807
topiramateTopiramate 100 mg/1Tablet, Film coatedOralAvPAK50268-808
topiramateTopiramate 200 mg/1Tablet, Film coatedOralAvPAK50268-809
topiramateTopiramate 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-429
topiramateTopiramate 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-746
topiramateTopiramate 100 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-848
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7142
topiramateTopiramate 25 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-075
topiramateTopiramate 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-577
topiramateTopiramate 25 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-647
topiramateTopiramate 50 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-648
topiramateTopiramate 100 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-649
topiramateTopiramate 200 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-650
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-0357

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