NDC codes

FDA NDC Directory
Product NDC (as listed)70518-1180Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-1180Add 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 NDC11-digit (billing)PackageCopy
70518-1180-3705181180037051811800330 POUCH in 1 BOX (70518-1180-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1180-2)Marketed from Jan 23, 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
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078235
Marketing start
Listing expires
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 70518-1180_5230d81d-b6b2-4cc4-e063-6294a90a31e6SPL ID 5230d81d-b6b2-4cc4-e063-6294a90a31e6SPL set ID 2f5b1b0b-fd8a-4c4e-a85a-519ca841a0dbRxCUI 151226UNII 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

N470518118003 followed by a unit qualifier and the quantity

Package 70518-1180-03. 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 .

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 70518-1180

What is NDC 70518-1180?
70518-1180 is the product NDC for topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, 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?
REMEDYREPACK INC., NDC labeler code 70518. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TopiramateTopiramate 25 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32527808-0325-01
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32627808-0326-01
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32727808-0327-01
TopiramateTopiramate 150 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32827808-0328-01
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32927808-0329-01
topiramateTopiramate 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-95260760-0952-60
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-035767046-0357-03
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-169167046-1691-03
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07987441-0079-01
TopiramateTopiramate 100 mg/1TabletOralCoupler LLC67046-168867046-1688-03

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
ProductStrengthForm · routeLabelerProduct NDC
topiramateTopiramate 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-577
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7142
topiramateTopiramate 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7146
topiramateTopiramate 25 mg/1Tablet, Film coatedOralProficient Rx LP71205-233
topiramateTopiramate 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1684
topiramateTopiramate 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1937
topiramateTopiramate 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1953
topiramateTopiramate 200 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2001
topiramateTopiramate 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2104
topiramateTopiramate 100 mg/1Tablet, Film coatedOralCoupler LLC67046-0357
topiramateTopiramate 25 mg/1Tablet, Film coatedOralCoupler LLC67046-0375
topiramateTopiramate 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7351
TopiramateTopiramate 25 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-342
TopiramateTopiramate 50 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-343
TopiramateTopiramate 100 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-344
TopiramateTopiramate 200 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-345
topiramateTopiramate 25 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7460
topiramateTopiramate 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7468
topiramateTopiramate 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6928
topiramateTopiramate 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6929

Showing 20 of 39.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in