Topiramate
- Product NDC
- 12634-083
- 11-digit product format
- 126340083
- Labeler code
- 12634
- Product ID
- 12634-083_35bd4587-6e8b-13a1-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 12634-083-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-40 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-42 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-45 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-52 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-54 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-57 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-59 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-61 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-63 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-66 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-67 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-69 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-71 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-74 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-78 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-79 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-81 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-82 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-84 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-85 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-91 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-92 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-93 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-94 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-95 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-96 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-97 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-98 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
| 12634-083-99 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f115-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12634-083-00 | Topiramate | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
| 12634-083-01 | Topiramate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 12634-083-09 | Topiramate | 35 in 1 BOTTLE | TABLET, FILM COATED | 35 | | 1 |
| 12634-083-40 | Topiramate | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 1 |
| 12634-083-42 | Topiramate | 42 in 1 BOTTLE | TABLET, FILM COATED | 42 | | 1 |
| 12634-083-45 | Topiramate | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 1 |
| 12634-083-50 | Topiramate | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 1 |
| 12634-083-52 | Topiramate | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 1 |
| 12634-083-54 | Topiramate | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 1 |
| 12634-083-57 | Topiramate | 20 in 1 BLISTER PACK | TABLET, FILM COATED | 20 | | 1 |
| 12634-083-59 | Topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 12634-083-60 | Topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 12634-083-61 | Topiramate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 1 |
| 12634-083-63 | Topiramate | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 1 |
| 12634-083-66 | Topiramate | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 1 |
| 12634-083-67 | Topiramate | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 1 |
| 12634-083-69 | Topiramate | 9 in 1 BLISTER PACK | TABLET, FILM COATED | 9 | | 1 |
| 12634-083-71 | Topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 12634-083-74 | Topiramate | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | | 1 |
| 12634-083-78 | Topiramate | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 1 |
| 12634-083-79 | Topiramate | 25 in 1 BOTTLE | TABLET, FILM COATED | 25 | | 1 |
| 12634-083-80 | Topiramate | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 12634-083-81 | Topiramate | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 1 |
| 12634-083-82 | Topiramate | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 1 |
| 12634-083-84 | Topiramate | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 1 |
| 12634-083-85 | Topiramate | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 12634-083-90 | Topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 12634-083-91 | Topiramate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 1 |
| 12634-083-92 | Topiramate | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 1 |
| 12634-083-93 | Topiramate | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 1 |
| 12634-083-94 | Topiramate | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 1 |
| 12634-083-95 | Topiramate | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 1 |
| 12634-083-96 | Topiramate | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 1 |
| 12634-083-97 | Topiramate | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 1 |
| 12634-083-98 | Topiramate | 8 in 1 BOTTLE | TABLET, FILM COATED | 8 | | 1 |
| 12634-083-99 | Topiramate | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-083 | TOPIRAMATE TABLET, FILM COATED [APOTHECA INC.] | 1 | Legacy NDC, 36 package rows | 20160621_35bd4587-6e8a-13a1-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-083-00 | 12634008300 | 10 in 1 BOTTLE | Historical |
| 12634-083-01 | 12634008301 | 100 in 1 BOTTLE | Historical |
| 12634-083-09 | 12634008309 | 35 in 1 BOTTLE | Historical |
| 12634-083-40 | 12634008340 | 40 in 1 BOTTLE | Historical |
| 12634-083-42 | 12634008342 | 42 in 1 BOTTLE | Historical |
| 12634-083-45 | 12634008345 | 45 in 1 BOTTLE | Historical |
| 12634-083-50 | 12634008350 | 50 in 1 BOTTLE | Historical |
| 12634-083-52 | 12634008352 | 12 in 1 BLISTER PACK | Historical |
| 12634-083-54 | 12634008354 | 14 in 1 BLISTER PACK | Historical |
| 12634-083-57 | 12634008357 | 20 in 1 BLISTER PACK | Historical |
| 12634-083-59 | 12634008359 | 30 in 1 BOTTLE | Historical |
| 12634-083-60 | 12634008360 | 60 in 1 BOTTLE | Historical |
| 12634-083-61 | 12634008361 | 10 in 1 BLISTER PACK | Historical |
| 12634-083-63 | 12634008363 | 3 in 1 BLISTER PACK | Historical |
| 12634-083-66 | 12634008366 | 6 in 1 BLISTER PACK | Historical |
| 12634-083-67 | 12634008367 | 7 in 1 BLISTER PACK | Historical |
| 12634-083-69 | 12634008369 | 9 in 1 BLISTER PACK | Historical |
| 12634-083-71 | 12634008371 | 30 in 1 BOTTLE | Historical |
| 12634-083-74 | 12634008374 | 24 in 1 BOTTLE | Historical |
| 12634-083-78 | 12634008378 | 28 in 1 BOTTLE | Historical |
| 12634-083-79 | 12634008379 | 25 in 1 BOTTLE | Historical |
| 12634-083-80 | 12634008380 | 20 in 1 BOTTLE | Historical |
| 12634-083-81 | 12634008381 | 21 in 1 BOTTLE | Historical |
| 12634-083-82 | 12634008382 | 12 in 1 BOTTLE | Historical |
| 12634-083-84 | 12634008384 | 14 in 1 BOTTLE | Historical |
| 12634-083-85 | 12634008385 | 15 in 1 BOTTLE | Historical |
| 12634-083-90 | 12634008390 | 90 in 1 BOTTLE | Historical |
| 12634-083-91 | 12634008391 | 1 in 1 BLISTER PACK | Historical |
| 12634-083-92 | 12634008392 | 2 in 1 BOTTLE | Historical |
| 12634-083-93 | 12634008393 | 3 in 1 BOTTLE | Historical |
| 12634-083-94 | 12634008394 | 4 in 1 BOTTLE | Historical |
| 12634-083-95 | 12634008395 | 5 in 1 BOTTLE | Historical |
| 12634-083-96 | 12634008396 | 6 in 1 BOTTLE | Historical |
| 12634-083-97 | 12634008397 | 7 in 1 BOTTLE | Historical |
| 12634-083-98 | 12634008398 | 8 in 1 BOTTLE | Historical |
| 12634-083-99 | 12634008399 | 9 in 1 BOTTLE | Historical |