What is NDC 68382-358?

68382-358 is the product NDC for Topiramate, Topiramate 200 mg/1 capsule, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-358 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0358Add 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
68382-358-01	68382035801	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-01)Marketed from Nov 13, 2023
68382-358-05	68382035805	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-05)Marketed from Nov 13, 2023
68382-358-06	68382035806	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-06)Marketed from Nov 13, 2023
68382-358-78	68382035878	3 BLISTER PACK in 1 CARTON (68382-358-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-358-30)Marketed from Nov 13, 2023

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 — 200 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207382
Marketing start: Nov 13, 2023
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 68382-358_2535bcc8-fac7-4b15-8c6f-fd6675655fd3SPL ID 2535bcc8-fac7-4b15-8c6f-fd6675655fd3SPL set ID f72774dd-c7eb-41f9-9837-02baf77cc523RxCUI 1436239, 1437278, 1437283, 1437288UNII 0H73WJJ391UPC 0368382863065, 0368382358066, 0368382864062

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

N468382035801 followed by a unit qualifier and the quantity

Package 68382-0358-01. 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 Mar 30, 2026.

Indications (excerpt from the label)

Topiramate extended-release capsules are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 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 extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-358

What is NDC 68382-358?: 68382-358 is the product NDC for Topiramate, Topiramate 200 mg/1 capsule, extended release, listed with the FDA by Zydus Pharmaceuticals USA 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 207382

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

FDA NDC Directory listings under ANDA 207382
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-769
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-863
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-864
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1315
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1316
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1317
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1858