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NDC 65862-0935-54 Aurovela 1.5/30 30; 1.5 ug/1; mg/1 Details
Aurovela 1.5/30 30; 1.5 ug/1; mg/1
Aurovela 1.5/30 is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ETHINYL ESTRADIOL; NORETHINDRONE ACETATE.
Product Information
| NDC | 65862-0935 |
|---|---|
| Product ID | 65862-935_07926174-446c-43dc-9db1-db8b78432645 |
| Associated GPIs | 25990002600320 |
| GCN Sequence Number | 003304 |
| GCN Sequence Number Description | norethindrone ac-eth estradiol TABLET 1.5-0.03MG ORAL |
| HIC3 | G8A |
| HIC3 Description | CONTRACEPTIVES,ORAL |
| GCN | 11480 |
| HICL Sequence Number | 001455 |
| HICL Sequence Number Description | NORETHINDRONE ACETATE-ETHINYL ESTRADIOL |
| Brand/Generic | Generic |
| Proprietary Name | Aurovela 1.5/30 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Norethindrone Acetate and Ethinyl Estradiol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 30; 1.5 |
| Active Ingredient Units | ug/1; mg/1 |
| Substance Name | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207581 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0935-54 (65862093554)
| NDC Package Code | 65862-935-54 |
|---|---|
| Billing NDC | 65862093554 |
| Package | 5 POUCH in 1 CARTON (65862-935-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2017-06-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |