Home NDC 51285-120-58 Mircette
Product NDC 51285-120
Requested package NDC 51285-120-58
11-digit product format 512850120
Labeler code 51285
Product ID 51285-120_85de2a58-5b5a-4bae-901b-2ca4f7d8533c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol
Dosage form KIT
Labeler Teva Women's Health, Inc.
Application ANDA075863
Marketing category ANDA
Marketing start 2014-09-15
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075863-001 KARIVA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075863-001 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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075863-001 KARIVA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB RS 2002-04-05 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESOGESTREL ACTIVE INGREDIENT 81K9V7M3A3 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 DESOGESTREL ACTIVE MOIETY 81K9V7M3A3 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRCETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.] 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 Kariva DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Teva Pharmaceuticals USA, Inc. 7b11e11f-6977-4109-b9bd-a066e5d1278a 2024-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075863 application number: ANDA075863
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51285-120-58 51285012058 6 POUCH in 1 CARTON (51285-120-58) > 1 BLISTER PACK in 1 POUCH (51285-120-79) > 1 KIT in 1 BLISTER PACK 6 pouch 2014-09-15 0000-00-00 No No Current