NDC codes

FDA NDC Directory
Product NDC (as listed)43063-734Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0734Add 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
43063-734-0743063073407430630734077 TABLET in 1 BOTTLE, PLASTIC (43063-734-07)Marketed from Mar 7, 2017
43063-734-21430630734214306307342121 TABLET in 1 BOTTLE, PLASTIC (43063-734-21)Marketed from Jan 31, 2017
43063-734-30430630734304306307343030 TABLET in 1 BOTTLE, PLASTIC (43063-734-30)Marketed from Jan 4, 2017
43063-734-60430630734604306307346060 TABLET in 1 BOTTLE, PLASTIC (43063-734-60)Marketed from Dec 28, 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 — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
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 43063-734_39f9738a-570e-d6a6-e063-6294a90ac1baSPL ID 39f9738a-570e-d6a6-e063-6294a90ac1baSPL set ID e39d2549-b489-426d-b576-741537e112e7RxCUI 151226UNII 0H73WJJ391UPC 0343063734308

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

N443063073407 followed by a unit qualifier and the quantity

Package 43063-0734-07. 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 43063-734

What is NDC 43063-734?
43063-734 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 4 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 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 25 mg/1TabletOralA-S Medication Solutions50090-4614
TopiramateTopiramate 200 mg/1TabletOralProficient Rx LP63187-963
TopiramateTopiramate 100 mg/1TabletOralCoupler LLC67046-1688
TopiramateTopiramate 25 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-1971
TopiramateTopiramate 25 mg/1TabletOralREMEDYREPACK INC.70518-0625
TopiramateTopiramate 50 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0195
TopiramateTopiramate 50 mg/1TabletOralA-S Medication Solutions50090-6828
TopiramateTopiramate 100 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3088
TopiramateTopiramate 25 mg/1TabletOralA-S Medication Solutions50090-6827
TopiramateTopiramate 50 mg/1TabletOralA-S Medication Solutions50090-3461
TopiramateTopiramate 25 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0208
TopiramateTopiramate 100 mg/1TabletOralProficient Rx LP63187-696
TopiramateTopiramate 200 mg/1TabletOralAsclemed USA, Inc.76420-280
TopiramateTopiramate 50 mg/1TabletOralAsclemed USA, Inc.76420-276
TopiramateTopiramate 25 mg/1TabletOralAsclemed USA, Inc.76420-278
TopiramateTopiramate 100 mg/1TabletOralAsclemed USA, Inc.76420-279
TopiramateTopiramate 100 mg/1TabletOralBryant Ranch Prepack71335-0337
TopiramateTopiramate 100 mg/1TabletOralC61919-213
TopiramateTopiramate 50 mg/1TabletOralNorthwind Health Company, LLC51655-606
TopiramateTopiramate 50 mg/1TabletOralProficient Rx LP63187-758

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