Carbamazepine
- Product NDC
- 21695-724
- 11-digit product format
- 216950724
- Labeler code
- 21695
- Product ID
- 21695-724_fc51bad7-8a77-4c0e-9ff8-fa3474796d35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA074649
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- CARBAMAZEPINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 26452c40-1589-928d-2fae-b84a1d1cf183 | Product name | 9 | 20251105 |
| 2275add5-bc9e-431c-8e27-74c11f3127d5 | Product name | 1 | 20200728 |
| 7c710123-0208-426b-be07-b37720f2767d | Product name | 1 | 20161206 |
| 8448f819-8511-2a70-1d0e-32e16eac918d | Product name | 1 | 20140508 |
| fee3eefd-cade-4e53-89b7-9d28964e1bc7 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-724-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ba2-48b1-e053-8cdaa90a720a | CARBAMAZEPINE TABLETS USP 200 mg Rx only |
| 21695-724-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ba2-48b1-e053-8cdaa90a720a | CARBAMAZEPINE TABLETS USP 200 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-724-30 | Carbamazepine | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 21695-724-60 | Carbamazepine | 60 in 1 BOTTLE | TABLET | 60 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-724-30 | EA - Each | 21695-724 | 226f7077-a23b-43f0-81b0-ebea7280a244 | 1 | 2012-07-24 |
| 21695-724-60 | EA - Each | 21695-724 | 333523d1-69c9-485d-8ba4-2e34180f5ca2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308979 | carBAMazepine 200 MG Oral Tablet | PSN | 25cca2b1-9020-4d8a-bc22-b8063e57f9e1 | 2 |
| 308979 | carbamazepine 200 MG Oral Tablet | SCD | 25cca2b1-9020-4d8a-bc22-b8063e57f9e1 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-724-30 | 21695072430 | 30 in 1 BOTTLE | Historical |
| 21695-724-60 | 21695072460 | 60 in 1 BOTTLE | Historical |