Prescription drug · ANDA

Topiramate NDC 70771-1315

Topiramate 25 mg/1 · Capsule, Extended release · Oral · Zydus Lifesciences Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1315Add 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
70771-1315-170771131501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1315-1)Marketed from Apr 5, 2018
70771-1315-37077113150330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1315-3)Marketed from Apr 5, 2018
70771-1315-47077113150410 BLISTER PACK in 1 CARTON (70771-1315-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1315-2)Marketed from Apr 5, 2018
70771-1315-570771131505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1315-5)Marketed from Apr 5, 2018
70771-1315-97077113150990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1315-9)Marketed from Apr 5, 2018

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 Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207382
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 70771-1315_709dd70b-24e1-435f-8373-02e6dd538b2cSPL ID 709dd70b-24e1-435f-8373-02e6dd538b2cSPL set ID 9a943af0-1c6d-43c2-830a-f303baa16124RxCUI 1436239, 1437278, 1437283, 1437288UNII 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

N470771131501 followed by a unit qualifier and the quantity

Package 70771-1315-01. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1315

What is NDC 70771-1315?
70771-1315 is the product NDC for Topiramate, Topiramate 25 mg/1 capsule, extended release, listed with the FDA by Zydus Lifesciences Limited. 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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 207382

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

FDA NDC Directory listings under ANDA 207382
ProductStrengthForm · routeLabelerProduct NDC
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-358
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-769
TopiramateTopiramate 25 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-863
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-864
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1316
TopiramateTopiramate 100 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1317
TopiramateTopiramate 200 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1858

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in