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NDC 60846-0232-01 Activella 1; .5 mg/1; mg/1 Details
Activella 1; .5 mg/1; mg/1
Activella is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is ESTRADIOL; NORETHINDRONE ACETATE.
Product Information
| NDC | 60846-0232 |
|---|---|
| Product ID | 60846-232_5be257d4-9989-4b95-8155-b92d77a74836 |
| Associated GPIs | 24993002120310 |
| GCN Sequence Number | 040888 |
| GCN Sequence Number Description | estradiol/norethindrone acet TABLET 1 MG-0.5MG ORAL |
| HIC3 | G1A |
| HIC3 Description | ESTROGENIC AGENTS |
| GCN | 95046 |
| HICL Sequence Number | 007310 |
| HICL Sequence Number Description | ESTRADIOL/NORETHINDRONE ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | Activella |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Estradiol/norethindrone acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 1; .5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ESTRADIOL; NORETHINDRONE ACETATE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020907 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 60846-0232-01 (60846023201)
| NDC Package Code | 60846-232-01 |
|---|---|
| Billing NDC | 60846023201 |
| Package | 1 BLISTER PACK in 1 CARTON (60846-232-01) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |