NDC codes

FDA NDC Directory
Product NDC (as listed)70710-1039Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-1039Add 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
70710-1039-37071010390330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-3)Marketed from Jan 17, 2023
70710-1039-97071010390990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-9)Marketed from Jan 17, 2023

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 — 25 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208949
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 70710-1039_bb736981-167f-4de6-a285-0e840ae37fc7SPL ID bb736981-167f-4de6-a285-0e840ae37fc7SPL set ID a5ca2fce-bd2d-40db-b963-e3ec27c8bf23RxCUI 1494769, 1812419, 1812421, 1812425, 1812427UNII 0H73WJJ391UPC 0370710104139, 0370710104030, 0370710104337, 0370710103934, 0370710104238

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

N470710103903 followed by a unit qualifier and the quantity

Package 70710-1039-03. 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 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70710-1039

What is NDC 70710-1039?
70710-1039 is the product NDC for Topiramate, Topiramate 25 mg/1 capsule, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 2 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 70710. 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 ANDA 208949

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

FDA NDC Directory listings under ANDA 208949
ProductStrengthForm · routeLabelerProduct NDC
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.70710-1040
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.70710-1041
TopiramateTopiramate 150 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.70710-1042
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.70710-1043
TopiramateTopiramate 25 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1656
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1657
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1658
TopiramateTopiramate 150 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1659
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1660

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