Topiramate
- Product NDC
- 12634-453
- 11-digit product format
- 126340453
- Labeler code
- 12634
- Product ID
- 12634-453_35ba1f4c-d50f-0bd5-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 50 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 |
|---|
| 12634-453-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-40 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-42 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-45 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-52 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-54 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-57 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-59 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-61 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-63 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-66 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-67 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-69 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-71 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-74 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-78 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-79 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-81 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-82 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-84 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-85 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-91 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-92 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-93 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-94 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-95 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-96 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-97 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-98 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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 |
| 12634-453-99 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c4ab-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#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET TOPIRAMATE TABLET [APOTHECA, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-453 | TOPIRAMATE TABLET [APOTHECA INC.] | 4 | Legacy NDC, 36 package rows | 20160621_3ac13777-45fb-45c2-84b8-d56aad796140.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-453-00 | 12634045300 | 10 in 1 BOTTLE | Historical |
| 12634-453-01 | 12634045301 | 100 in 1 BOTTLE | Historical |
| 12634-453-09 | 12634045309 | 35 in 1 BOTTLE | Historical |
| 12634-453-40 | 12634045340 | 40 in 1 BOTTLE | Historical |
| 12634-453-42 | 12634045342 | 42 in 1 BOTTLE | Historical |
| 12634-453-45 | 12634045345 | 45 in 1 BOTTLE | Historical |
| 12634-453-50 | 12634045350 | 50 in 1 BOTTLE | Historical |
| 12634-453-52 | 12634045352 | 12 in 1 BLISTER PACK | Historical |
| 12634-453-54 | 12634045354 | 14 in 1 BLISTER PACK | Historical |
| 12634-453-57 | 12634045357 | 20 in 1 BLISTER PACK | Historical |
| 12634-453-59 | 12634045359 | 30 in 1 BLISTER PACK | Historical |
| 12634-453-60 | 12634045360 | 60 in 1 BOTTLE | Historical |
| 12634-453-61 | 12634045361 | 10 in 1 BLISTER PACK | Historical |
| 12634-453-63 | 12634045363 | 3 in 1 BOTTLE | Historical |
| 12634-453-66 | 12634045366 | 6 in 1 BLISTER PACK | Historical |
| 12634-453-67 | 12634045367 | 7 in 1 BLISTER PACK | Historical |
| 12634-453-69 | 12634045369 | 9 in 1 BLISTER PACK | Historical |
| 12634-453-71 | 12634045371 | 30 in 1 BOTTLE | Historical |
| 12634-453-74 | 12634045374 | 24 in 1 BOTTLE | Historical |
| 12634-453-78 | 12634045378 | 28 in 1 BOTTLE | Historical |
| 12634-453-79 | 12634045379 | 25 in 1 BOTTLE | Historical |
| 12634-453-80 | 12634045380 | 20 in 1 BOTTLE | Historical |
| 12634-453-81 | 12634045381 | 21 in 1 BOTTLE | Historical |
| 12634-453-82 | 12634045382 | 12 in 1 BOTTLE | Historical |
| 12634-453-84 | 12634045384 | 14 in 1 BOTTLE | Historical |
| 12634-453-85 | 12634045385 | 15 in 1 BOTTLE | Historical |
| 12634-453-90 | 12634045390 | 90 in 1 BOTTLE | Historical |
| 12634-453-91 | 12634045391 | 1 in 1 BLISTER PACK | Historical |
| 12634-453-92 | 12634045392 | 2 in 1 BOTTLE | Historical |
| 12634-453-93 | 12634045393 | 3 in 1 BOTTLE | Historical |
| 12634-453-94 | 12634045394 | 4 in 1 BOTTLE | Historical |
| 12634-453-95 | 12634045395 | 5 in 1 BOTTLE | Historical |
| 12634-453-96 | 12634045396 | 6 in 1 BOTTLE | Historical |
| 12634-453-97 | 12634045397 | 7 in 1 BOTTLE | Historical |
| 12634-453-98 | 12634045398 | 8 in 1 BOTTLE | Historical |
| 12634-453-99 | 12634045399 | 9 in 1 BOTTLE | Historical |