Home NDC 68180-846 Daysee
Product NDC 68180-846
11-digit product format 681800846
Labeler code 68180
Product ID 68180-846_6b987938-9b90-412f-bb40-77cc523fd908
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVONORGESTREL AND ETHINYL ESTRADIOL
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA091467
Marketing category ANDA
Marketing start 2013-04-10
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A091467-001 DAYSEE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091467-001 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 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 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.
Additional Listing Data#
Finished product Yes
Brand name base Daysee
Listing expiration 2027-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-846-13 Daysee 1 in 1 POUCH KIT 1 17 68180-846-13 Daysee 2 in 1 CARTON KIT 2 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-846 DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20250515_a9861412-4e54-4984-b14c-a1dd91d5c946.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 Daysee LEVONORGESTREL AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. a9861412-4e54-4984-b14c-a1dd91d5c946 2026-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091467 application number: ANDA091467 ndc (product): 68180-846
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 68180-846-13 68180084613 2 POUCH in 1 CARTON (68180-846-13) > 1 BLISTER PACK in 1 POUCH (68180-846-11) > 1 KIT in 1 BLISTER PACK 2 pouch 2013-04-10 0000-00-00 No No Current 68180-846-73 68180084673 2 POUCH in 1 CARTON (68180-846-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 2 pouch 2013-04-10 No No Historical