| NDC Code | 46708-422-91 |
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| Package Description | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-422-91) |
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| Product NDC | 46708-422 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Carbamazepine |
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| Non-Proprietary Name | Carbamazepine |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20250726 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA219939 |
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| Manufacturer | Alembic Pharmaceuticals Limited |
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| Substance Name | CARBAMAZEPINE |
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| Strength | 400 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC] |
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