Home NDC 0093-5455 Mimvey
Product NDC 0093-5455
11-digit product format 000935455
Labeler code 0093
Product ID 0093-5455_2704fcb9-da21-461e-b6ba-b196b2f2bf4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol and Norethindrone Acetate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA079193
Marketing category ANDA
Marketing start 2010-06-02
Substance ESTRADIOL; NORETHINDRONE ACETATE
Active strength 1; .5 mg/1; mg/1
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079193-001 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2010-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079193-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A079193-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2010-05-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A079193-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mimvey ESTRADIOL AND NORETHINDRONE ACETATE Teva Pharmaceuticals USA, Inc. b1c5c06b-9ce2-4bf7-9693-e37608055a14 2024-05-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079193 application number: ANDA079193 ndc (product): 0093-5455
Additional Listing Data#
Finished product Yes
Brand name base Mimvey
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL 1 mg/1 NORETHINDRONE ACETATE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4TI98Z838E Internal UNII lookup 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359126 Internal RxNorm lookup 1359127 Internal RxNorm lookup 1359129 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-5455-28 Mimvey 28 in 1 BLISTER PACK TABLET, FILM COATED 28 16 0093-5455-28 Mimvey 1 in 1 CARTON TABLET, FILM COATED 1 16 0093-5455-42 Mimvey 5 in 1 CARTON TABLET, FILM COATED 5 16 0093-5455-42 Mimvey 28 in 1 BLISTER PACK TABLET, FILM COATED 28 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESTRADIOL ACTIVE INGREDIENT 4TI98Z838E MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 NORETHINDRONE ACETATE ACTIVE INGREDIENT 9S44LIC7OJ MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 ESTRADIOL ACTIVE MOIETY 4TI98Z838E MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 NORETHINDRONE ACTIVE MOIETY T18F433X4S MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-5455 MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 16 Current NDC, Legacy NDC, 4 package rows 20240719_b1c5c06b-9ce2-4bf7-9693-e37608055a14.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-5455-28 00093545528 1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2010-06-02 0000-00-00 No No Current 0093-5455-42 00093545542 5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACK 5 blister pack 2010-06-02 0000-00-00 No No Current