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NDC 00121-1894-94 Carbamazepine 200 mg/10mL Details
Carbamazepine 200 mg/10mL
Carbamazepine is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is CARBAMAZEPINE.
MedlinePlus Drug Summary
Carbamazepine is used alone or in combination with other medications to control certain types of seizures in people with epilepsy. It is also used to treat trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine extended-release capsules (Equetro brand only) are also used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen at the same time) in patients with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Carbamazepine is in a class of medications called anticonvulsants. It works by reducing abnormal electrical activity in the brain.
Related Packages: 00121-1894-94Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Carbamazepine
Product Information
| NDC | 00121-1894 |
|---|---|
| Product ID | 0121-1894_c64c38ed-d17b-47d3-9538-23663d4c4027 |
| Associated GPIs | 72600020001810 |
| GCN Sequence Number | 065594 |
| GCN Sequence Number Description | carbamazepine ORAL SUSP 200MG/10ML ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 27602 |
| HICL Sequence Number | 001893 |
| HICL Sequence Number Description | CARBAMAZEPINE |
| Brand/Generic | Generic |
| Proprietary Name | Carbamazepine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Carbamazepine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/10mL |
| Substance Name | CARBAMAZEPINE |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | 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], Mo |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076729 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-1894-94 (00121189494)
| NDC Package Code | 0121-1894-94 |
|---|---|
| Billing NDC | 00121189494 |
| Package | 3 TRAY in 1 CASE (0121-1894-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1894-10) |
| Marketing Start Date | 2021-10-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |