NDC codes

FDA NDC Directory
Product NDC (as listed)63187-773Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0773Add 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
63187-773-306318707733030 TABLET in 1 BOTTLE (63187-773-30)Marketed from Nov 1, 2016
63187-773-606318707736060 TABLET in 1 BOTTLE (63187-773-60)Marketed from Nov 1, 2016
63187-773-906318707739090 TABLET in 1 BOTTLE (63187-773-90)Marketed from Nov 1, 2016

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
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076343
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 63187-773_a3b868e4-d9b8-4e48-a11e-8bf67f9f4b52SPL ID a3b868e4-d9b8-4e48-a11e-8bf67f9f4b52SPL set ID 2917ba32-3355-4d64-966a-8518e6fafdbeRxCUI 199888UNII 0H73WJJ391UPC 0363187773304

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

N463187077330 followed by a unit qualifier and the quantity

Package 63187-0773-30. 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 tablets USP is an antiepileptic (AED) agent indicated for: • Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1 ) • Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) ( 1.2 ) 1.1 Monotherapy Epilepsy Topiramate tablets USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effect…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-773

What is NDC 63187-773?
63187-773 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, 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 63187. 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 076343

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

FDA NDC Directory listings under ANDA 076343
ProductStrengthForm · routeLabelerProduct NDC
TopiramateTopiramate 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-729
TopiramateTopiramate 50 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-734
TopiramateTopiramate 25 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-735
TopiramateTopiramate 100 mg/1TabletOralA-S Medication Solutions50090-3389
TopiramateTopiramate 50 mg/1TabletOralA-S Medication Solutions50090-3461
TopiramateTopiramate 25 mg/1TabletOralA-S Medication Solutions50090-4614
TopiramateTopiramate 25 mg/1TabletOralA-S Medication Solutions50090-6827
TopiramateTopiramate 50 mg/1TabletOralA-S Medication Solutions50090-6828
TopiramateTopiramate 100 mg/1TabletOralA-S Medication Solutions50090-6895
TopiramateTopiramate 50 mg/1TabletOralNorthwind Health Company, LLC51655-606
TopiramateTopiramate 100 mg/1TabletOralC61919-213
TopiramateTopiramate 100 mg/1TabletOralProficient Rx LP63187-696
TopiramateTopiramate 50 mg/1TabletOralProficient Rx LP63187-758
TopiramateTopiramate 200 mg/1TabletOralProficient Rx LP63187-963
TopiramateTopiramate 100 mg/1TabletOralCoupler LLC67046-1688
TopiramateTopiramate 25 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-1971
TopiramateTopiramate 100 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3088
TopiramateTopiramate 25 mg/1TabletOralCipla USA Inc.69097-122
TopiramateTopiramate 50 mg/1TabletOralCipla USA Inc.69097-123
TopiramateTopiramate 100 mg/1TabletOralCipla USA Inc.69097-124

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