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NDC 51285-0131-97 Loestrin 20; 1 ug/1; mg/1 Details
Loestrin 20; 1 ug/1; mg/1
Loestrin is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Teva Women's Health LLC. The primary component is ETHINYL ESTRADIOL; NORETHINDRONE ACETATE.
Product Information
NDC | 51285-0131 |
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Product ID | 51285-131_ac1ba264-f0d0-4aea-b392-66924639042b |
Associated GPIs | 25990002600310 |
GCN Sequence Number | 003305 |
GCN Sequence Number Description | norethindrone ac-eth estradiol TABLET 1MG-20MCG ORAL |
HIC3 | G8A |
HIC3 Description | CONTRACEPTIVES,ORAL |
GCN | 11481 |
HICL Sequence Number | 001455 |
HICL Sequence Number Description | NORETHINDRONE ACETATE-ETHINYL ESTRADIOL |
Brand/Generic | Brand |
Proprietary Name | Loestrin |
Proprietary Name Suffix | 21 Day |
Non-Proprietary Name | Norethindrone Acetate and Ethinyl Estradiol |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 20; 1 |
Active Ingredient Units | ug/1; mg/1 |
Substance Name | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
Labeler Name | Teva Women's Health LLC |
Pharmaceutical Class | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA076380 |
Listing Certified Through | 2024-12-31 |
Package
NDC 51285-0131-97 (51285013197)
NDC Package Code | 51285-131-97 |
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Billing NDC | 51285013197 |
Package | 5 POUCH in 1 CARTON (51285-131-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK |
Marketing Start Date | 2015-02-26 |
NDC Exclude Flag | N |
Pricing Information | N/A |