Oxcarbazepine
- Product NDC
- 70518-3197
- 11-digit product format
- 705183197
- Labeler code
- 70518
- Product ID
- 70518-3197_4ece29f3-241b-21d8-e063-6394a90aa62a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077802
- Marketing category
- ANDA
- Marketing start
- 2021-08-18
- Substance
- OXCARBAZEPINE
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxcarbazepine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXCARBAZEPINE | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 312138 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-3197-0 | 2023-03-21 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
| 70518-3197-0 | 2023-03-21 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
| 70518-3197-1 | 2023-03-21 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
| 70518-3197-1 | 2023-03-21 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
| 70518-3197-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
| 70518-3197-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
| 70518-3197-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
| 70518-3197-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-99de-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3197-0 | Oxcarbazepine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 9 |
| 70518-3197-1 | Oxcarbazepine | 100 in 1 BOX | TABLET, FILM COATED | 100 | | 9 |
| 70518-3197-2 | Oxcarbazepine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 9 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3197-0 | 70518319700 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3197-0) | | 2021-08-18 | 0000-00-00 | No | No | Current |
| 70518-3197-1 | 70518319701 | 100 POUCH in 1 BOX (70518-3197-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3197-2) | 100 pouch | 2021-10-07 | 0000-00-00 | No | No | Current |
| 70518-3197-2 | 70518319702 | 1 in 1 POUCH | | | | | | Historical |