What is NDC 68071-1971?

68071-1971 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 68071-1971 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-1971Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-1971Add 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
68071-1971-3	6807119710368071197103	30 TABLET in 1 BOTTLE (68071-1971-3)Marketed from Feb 21, 2017
68071-1971-6	6807119710668071197106	60 TABLET in 1 BOTTLE (68071-1971-6)Marketed from Feb 21, 2017
68071-1971-9	6807119710968071197109	90 TABLET in 1 BOTTLE (68071-1971-9)Marketed from Feb 21, 2017

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
Route: Oral
Labeler: NuCare Pharmaceuticals, Inc.NDC labeler code 68071
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 68071-1971_3ab5a044-1530-14af-e063-6394a90a35caSPL ID 3ab5a044-1530-14af-e063-6394a90a35caSPL set ID 490f109f-30cb-0790-e054-00144ff88e88RxCUI 199888UNII 0H73WJJ391UPC 0368071197198

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

N468071197103 followed by a unit qualifier and the quantity

Package 68071-1971-03. 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 Jul 24, 2025.

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 effectiven…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-1971

What is NDC 68071-1971?: 68071-1971 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, listed with the FDA by NuCare 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?: NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 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 25 mg/1	TabletOral	A-S Medication Solutions	50090-4614
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	REMEDYREPACK INC.	70518-0625
Topiramate	Topiramate 50 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0195
Topiramate	Topiramate 50 mg/1	TabletOral	A-S Medication Solutions	50090-6828
Topiramate	Topiramate 100 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3088
Topiramate	Topiramate 25 mg/1	TabletOral	A-S Medication Solutions	50090-6827
Topiramate	Topiramate 50 mg/1	TabletOral	A-S Medication Solutions	50090-3461
Topiramate	Topiramate 25 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0208
Topiramate	Topiramate 100 mg/1	TabletOral	Proficient Rx LP	63187-696
Topiramate	Topiramate 200 mg/1	TabletOral	Asclemed USA, Inc.	76420-280
Topiramate	Topiramate 50 mg/1	TabletOral	Asclemed USA, Inc.	76420-276
Topiramate	Topiramate 25 mg/1	TabletOral	Asclemed USA, Inc.	76420-278
Topiramate	Topiramate 100 mg/1	TabletOral	Asclemed USA, Inc.	76420-279
Topiramate	Topiramate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-0337
Topiramate	Topiramate 100 mg/1	TabletOral	C	61919-213
Topiramate	Topiramate 50 mg/1	TabletOral	Northwind Health Company, LLC	51655-606
Topiramate	Topiramate 50 mg/1	TabletOral	Proficient Rx LP	63187-758
Topiramate	Topiramate 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-734

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