Carbamazepine
- Product NDC
- 64725-4005
- 11-digit product format
- 647254005
- Labeler code
- 64725
- Product ID
- 64725-4005_bd525ac0-d234-4a1d-936a-7c485882b41f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA074649
- Marketing category
- ANDA
- Marketing start
- 1996-10-03
- 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 |
|---|---|---|---|---|---|
| 64725-4005-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-484b-60a7-e053-dbdaa90a05bd | Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-4005-1 | Carbamazepine | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Carbamazepine | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 | |
| Carbamazepine | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-4005 | CARBAMAZEPINE TABLET [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20140901_19fa8a00-51a0-4f8f-8060-45f7053ceb29.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308979 | carBAMazepine 200 MG Oral Tablet | PSN | 19fa8a00-51a0-4f8f-8060-45f7053ceb29 | 2 |
| 308979 | carbamazepine 200 MG Oral Tablet | SCD | 19fa8a00-51a0-4f8f-8060-45f7053ceb29 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-4005-1 | 64725400501 | 100 in 1 BOTTLE | Historical |