Home NDC 68180-846-13 Daysee
Product NDC 68180-846
Requested package NDC 68180-846-13
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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A091467-001 DAYSEE 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2013-04-10 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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
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 / 1 KIT in 1 BLISTER PACK 2 pouch 2013-04-10 2027-06-30 No No Current