What is NDC 68788-7351?

68788-7351 is the product NDC for topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 68788-7351 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-7351Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-7351Add 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
68788-7351-1	6878873510168788735101	100 TABLET, FILM COATED in 1 BOTTLE (68788-7351-1)Marketed from Feb 27, 2019
68788-7351-3	6878873510368788735103	30 TABLET, FILM COATED in 1 BOTTLE (68788-7351-3)Marketed from Feb 27, 2019
68788-7351-5	6878873510568788735105	15 TABLET, FILM COATED in 1 BOTTLE (68788-7351-5)Marketed from Feb 27, 2019
68788-7351-6	6878873510668788735106	60 TABLET, FILM COATED in 1 BOTTLE (68788-7351-6)Marketed from Feb 27, 2019
68788-7351-9	6878873510968788735109	90 TABLET, FILM COATED in 1 BOTTLE (68788-7351-9)Marketed from Feb 27, 2019

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, Film coated
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078235
Marketing start: Feb 27, 2019
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 68788-7351_121d32bf-69da-4714-aff6-1ac13caafe54SPL ID 121d32bf-69da-4714-aff6-1ac13caafe54

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

N468788735101 followed by a unit qualifier and the quantity

Package 68788-7351-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68788-7351

What is NDC 68788-7351?: 68788-7351 is the product NDC for topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 078235

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

FDA NDC Directory listings under ANDA 078235
Product	Strength	Form · route	Labeler	Product NDC
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-577
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7142
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7146
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-233
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1684
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1937
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1953
topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2001
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2104
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0357
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0375
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-342
Topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-343
Topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-344
Topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-345
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-7460
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7468
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1180
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6928
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6929

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