NDC codes

FDA NDC Directory
Product NDC (as listed)0832-1075Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00832-1075Add 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
0832-1075-1500832107515500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1075-15)Marketed from Jul 7, 2014
0832-1075-30008321075301 BOTTLE in 1 CARTON (0832-1075-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 7, 2014
0832-1075-90008321075901 BOTTLE in 1 CARTON (0832-1075-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 7, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 150 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Upsher-Smith Laboratories, LLCNDC labeler code 0832
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 205122
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 0832-1075_1be5841a-e872-475c-bfe9-859be4ba4001SPL ID 1be5841a-e872-475c-bfe9-859be4ba4001SPL set ID 691d276c-9cc1-4d39-828f-0f44d7ef6328RxCUI 1494769, 1812419, 1812421, 1812425, 1812427UNII 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

N400832107515 followed by a unit qualifier and the quantity

Package 00832-1075-15. 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 extended-release capsules are 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 extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age an…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0832-1075

What is NDC 0832-1075?
0832-1075 is the product NDC for Topiramate, Topiramate 150 mg/1 capsule, extended release, listed with the FDA by Upsher-Smith Laboratories, LLC. 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?
Upsher-Smith Laboratories, LLC, NDC labeler code 0832. 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
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 277 Topiramate NDCs

Other NDCs under NDA 205122

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

FDA NDC Directory listings under NDA 205122
ProductStrengthForm · routeLabelerProduct NDC
Qudexy XRtopiramateTopiramate 25 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0245-1071
Qudexy XRtopiramateTopiramate 50 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0245-1072
Qudexy XRtopiramateTopiramate 200 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0245-1073
Qudexy XRtopiramateTopiramate 100 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0245-1074
Qudexy XRtopiramateTopiramate 150 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0245-1075
TopiramateTopiramate 25 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0832-1071
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0832-1072
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0832-1073
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0832-1074

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