Home NDC 0555-9123 Jolessa
Product NDC 0555-9123
11-digit product format 005559123
Labeler code 0555
Product ID 0555-9123_2b5bb263-c949-4464-b59a-49e78ba3d94c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel / Ethinyl Estradiol
Dosage form KIT
Labeler Teva Pharmaceuticals USA, Inc.
Application NDA021544
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2003-10-13
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 N021544-001 SEASONALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021544-001 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 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021544-001 SEASONALE 0.03MG;0.15MG TABLET / ORAL AB RLD, RS 2003-09-05 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.
Additional Listing Data#
Finished product Yes
Brand name base Jolessa
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 0555-9123-66 Jolessa 3 in 1 CARTON KIT 3 18 0555-9123-66 Jolessa 1 in 1 POUCH KIT 1 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 HYPROMELLOSE 2208 (15000 MPA.S) INACTIVE INGREDIENT Z78RG6M2N2 JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 5 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSE 2208 (15000 MPA.S) INACTIVE INGREDIENT Z78RG6M2N2 JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP JOLESSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-9123 JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20241027_f1076019-6f2c-4c90-9f3c-ab0c7cdd9315.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 0555-9123-66 00555912366 3 POUCH in 1 CARTON (0555-9123-66) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 3 pouch 2003-10-13 0000-00-00 No No Current