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NDC 64380-0203-01 Doxepin 3 mg/1 Details
Doxepin 3 mg/1
Doxepin is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is DOXEPIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Doxepin is used to treat depression and anxiety. Doxepin is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed for mental balance. Doxepin is also available as a tablet to treat insomnia. This monograph only gives information about doxepin for depression or anxiety. If you are using this medication for insomnia, read the monograph entitled doxepin (insomnia).
Related Packages: 64380-0203-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxepin (Depression, Anxiety)
Doxepin (Silenor) is used to treat insomnia (difficulty falling asleep or staying asleep) in people who have trouble staying asleep. Doxepin (Silenor) is in a class of medications called tricyclic antidepressants. It works by slowing activity in the brain to allow sleep. Doxepin is also available as a capsule and liquid to treat depression and anxiety. This monograph only gives information about doxepin (Silenor) for insomnia. If you are using this medication for depression or anxiety, read the monograph entitled doxepin (depression, anxiety).
Related Packages: 64380-0203-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxepin (Insomnia)
Product Information
| NDC | 64380-0203 |
|---|---|
| Product ID | 64380-203_bac2d7a8-110c-4eb6-bc41-105f38713254 |
| Associated GPIs | |
| GCN Sequence Number | 066591 |
| GCN Sequence Number Description | doxepin HCl TABLET 3 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 28914 |
| HICL Sequence Number | 001650 |
| HICL Sequence Number Description | DOXEPIN HCL |
| Brand/Generic | Generic |
| Proprietary Name | Doxepin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | doxepin hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/1 |
| Substance Name | DOXEPIN HYDROCHLORIDE |
| Labeler Name | Strides Pharma Science Limited |
| Pharmaceutical Class | Tricyclic Antidepressant [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202510 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64380-0203-01 (64380020301)
| NDC Package Code | 64380-203-01 |
|---|---|
| Billing NDC | 64380020301 |
| Package | 30 TABLET in 1 BOTTLE, PLASTIC (64380-203-01) |
| Marketing Start Date | 2022-09-12 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 4.44311 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DOXEPIN HCL 3 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |