What is NDC 50090-3461?

50090-3461 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 4 package NDCs, shown above in 10- and 11-digit form.

A-S Medication Solutions, NDC labeler code 50090. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topiramate NDC 50090-3461 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-3461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-3461Add 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
50090-3461-0	50090346100	60 TABLET in 1 BOTTLE (50090-3461-0)Marketed from May 22, 2018
50090-3461-1	50090346101	90 TABLET in 1 BOTTLE (50090-3461-1)Marketed from May 23, 2018
50090-3461-2	50090346102	120 TABLET in 1 BOTTLE (50090-3461-2)Marketed from Jun 4, 2018
50090-3461-3	50090346103	180 TABLET in 1 BOTTLE (50090-3461-3)Marketed from Nov 20, 2023

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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: A-S Medication SolutionsNDC labeler code 50090
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076343
Marketing start: Jun 12, 2014
Listing expires: Dec 31, 2026
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 50090-3461_c3bc6965-397a-4657-ae62-c05a29568265SPL ID c3bc6965-397a-4657-ae62-c05a29568265SPL set ID f16b14a2-297f-4adb-8d7a-5f43785faef7RxCUI 151226, 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

N450090346100 followed by a unit qualifier and the quantity

Package 50090-3461-00. 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

Current FDA label (SPL), effective Jun 9, 2025.

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 50090-3461

What is NDC 50090-3461?: 50090-3461 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, listed with the FDA by A-S Medication Solutions. 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?: A-S Medication Solutions, NDC labeler code 50090. 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
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 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
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-729
Topiramate	Topiramate 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-734
Topiramate	Topiramate 25 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-735
Topiramate	Topiramate 100 mg/1	TabletOral	A-S Medication Solutions	50090-3389
Topiramate	Topiramate 25 mg/1	TabletOral	A-S Medication Solutions	50090-4614
Topiramate	Topiramate 25 mg/1	TabletOral	A-S Medication Solutions	50090-6827
Topiramate	Topiramate 50 mg/1	TabletOral	A-S Medication Solutions	50090-6828
Topiramate	Topiramate 100 mg/1	TabletOral	A-S Medication Solutions	50090-6895
Topiramate	Topiramate 50 mg/1	TabletOral	Northwind Health Company, LLC	51655-606
Topiramate	Topiramate 100 mg/1	TabletOral	C	61919-213
Topiramate	Topiramate 100 mg/1	TabletOral	Proficient Rx LP	63187-696
Topiramate	Topiramate 50 mg/1	TabletOral	Proficient Rx LP	63187-758
Topiramate	Topiramate 25 mg/1	TabletOral	Proficient Rx LP	63187-773
Topiramate	Topiramate 200 mg/1	TabletOral	Proficient Rx LP	63187-963
Topiramate	Topiramate 100 mg/1	TabletOral	Coupler LLC	67046-1688
Topiramate	Topiramate 25 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-1971
Topiramate	Topiramate 100 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3088
Topiramate	Topiramate 25 mg/1	TabletOral	Cipla USA Inc.	69097-122
Topiramate	Topiramate 50 mg/1	TabletOral	Cipla USA Inc.	69097-123
Topiramate	Topiramate 100 mg/1	TabletOral	Cipla USA Inc.	69097-124

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