What is NDC 68382-005?

68382-005 is the product NDC for topiramate, Topiramate 25 mg/1 capsule, coated pellets, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 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?

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 68382-005 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0005Add 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
68382-005-01	6838200050168382000501	100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-01)Marketed from Oct 14, 2009
68382-005-05	6838200050568382000505	500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-05)Marketed from Oct 14, 2009
68382-005-10	6838200051068382000510	1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-10)Marketed from Oct 14, 2009
68382-005-14	6838200051468382000514	60 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-14)Marketed from Oct 14, 2009
68382-005-16	6838200051668382000516	90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-16)Marketed from Oct 14, 2009
68382-005-17	6838200051768382000517	28 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-005-17)Marketed from Oct 14, 2009

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 — 25 mg/1
Dosage form: Capsule, Coated pellets
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 078877
Marketing start: Oct 14, 2009
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 68382-005_69df5f84-1db1-4eb2-ae32-462137a4d812SPL ID 69df5f84-1db1-4eb2-ae32-462137a4d812SPL set ID e4886adf-199d-4b19-a4ef-75f8f94cb54eRxCUI 205315, 205316, 252413UNII 0H73WJJ391UPC 0368382005144

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

N468382000501 followed by a unit qualifier and the quantity

Package 68382-0005-01. 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 Apr 22, 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 and topiramate capsules 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 Adjun…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-005

What is NDC 68382-005?: 68382-005 is the product NDC for topiramate, Topiramate 25 mg/1 capsule, coated pellets, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 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?: 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 078877

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

FDA NDC Directory listings under ANDA 078877
Product	Strength	Form · route	Labeler	Product NDC
topiramate	Topiramate 15 mg/1	Capsule, Coated pelletsOral	Zydus Lifesciences Limited	65841-651
topiramate	Topiramate 25 mg/1	Capsule, Coated pelletsOral	Zydus Lifesciences Limited	65841-652
topiramate	Topiramate 50 mg/1	Capsule, Coated pelletsOral	Zydus Lifesciences Limited	65841-846
topiramate	Topiramate 15 mg/1	Capsule, Coated pelletsOral	Zydus Pharmaceuticals USA Inc.	68382-004
topiramate	Topiramate 50 mg/1	Capsule, Coated pelletsOral	Zydus Pharmaceuticals USA Inc.	68382-498
topiramate	Topiramate 25 mg/1	Capsule, Coated pelletsOral	REMEDYREPACK INC.	70518-4247