Home NDC 68180-891 ENSKYCE
Product NDC 68180-891
11-digit product format 681800891
Labeler code 68180
Product ID 68180-891_0df0b7c1-f980-49d0-b282-99c93fb7dcbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desogestrel and ethinyl estradiol
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA201887
Marketing category ANDA
Marketing start 2020-02-08
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68180-891-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-891-13 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-891-13 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-891-13 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-891-13 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-891-13 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-891-13 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-891-13 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-891-13 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-891-13 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-891-13 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-891-13 557ba5c1ecfa…9c80585c8c6e…
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 A201887-001 ENSKYCE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201887-001 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 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201887-001 ENSKYCE 0.15MG;0.03MG TABLET / ORAL-28 AB 2013-03-07 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-891-73 ENSKYCE 1 in 1 POUCH KIT 1 4 68180-891-73 ENSKYCE 3 in 1 CARTON KIT 3 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESOGESTREL ACTIVE INGREDIENT 81K9V7M3A3 ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 DESOGESTREL ACTIVE MOIETY 81K9V7M3A3 ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 ENSKYCE ( DESOGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-891 ENSKYCE (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 Legacy NDC, 2 package rows 20231216_33ae0cc9-a797-4476-8283-bc4603aae10d.zip
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 ENSKYCE DESOGESTREL AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. 799fa1d8-4e7b-4b5e-844d-d638896a4b02 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201887 application number: ANDA201887
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 68180-891-13 68180089113 3 POUCH in 1 CARTON (68180-891-13) > 1 BLISTER PACK in 1 POUCH (68180-891-11) > 1 KIT in 1 BLISTER PACK 3 pouch 2018-01-20 2022-04-30 No No Current 68180-891-73 68180089173 3 POUCH in 1 CARTON (68180-891-73) > 1 BLISTER PACK in 1 POUCH (68180-891-71) > 1 KIT in 1 BLISTER PACK 3 pouch 2020-02-08 0000-00-00 No No Current