What is NDC 43063-997?

43063-997 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topiramate NDC 43063-997 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43063-997Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43063-0997Add 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 NDC	11-digit (billing)	Package
43063-997-21	4306309972143063099721	21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-997-21)Marketed from Apr 21, 2020
43063-997-30	4306309973043063099730	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-997-30)Marketed from Aug 23, 2020
43063-997-60	4306309976043063099760	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-997-60)Marketed from Jul 18, 2020

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, Film coated
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 090278
Marketing start: Dec 15, 2014
Listing expires: Dec 31, 2027
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 43063-997_53c54f71-19c3-4768-e063-6394a90a0cf0SPL ID 53c54f71-19c3-4768-e063-6394a90a0cf0SPL set ID 1b847969-2124-4350-94b0-ef5ba707673bRxCUI 151226UNII 0H73WJJ391UPC 0343063997307

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

N443063099721 followed by a unit qualifier and the quantity

Package 43063-0997-21. 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 Jun 8, 2026.

Indications (excerpt from the label)

Topiramate is 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 Epilepsy Topira…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-997

What is NDC 43063-997?: 43063-997 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. 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?: 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-325	27808-0325-01
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-326	27808-0326-01
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-327	27808-0327-01
Topiramate	Topiramate 150 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-328	27808-0328-01
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-329	27808-0329-01
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-952	60760-0952-60
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0357	67046-0357-03
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1691	67046-1691-03
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-079	87441-0079-01
Topiramate	Topiramate 100 mg/1	TabletOral	Coupler LLC	67046-1688	67046-1688-03

All 278 Topiramate NDCs

Other NDCs under ANDA 090278

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

FDA NDC Directory listings under ANDA 090278
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-819
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-998
Topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-712
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-710
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-711
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5165
Topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0925
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0325
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-801
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-707
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-004
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0487
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	62756-710
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	62756-707
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	62756-711
Topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	62756-712
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-060
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0548
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-059
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-077

Showing 20 of 21.