Home NDC 0555-9014 Lessina
Product NDC 0555-9014
11-digit product format 005559014
Labeler code 0555
Product ID 0555-9014_02883b10-2ca4-4a70-a1c6-4bfc1604a15e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form KIT
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA075803
Marketing category ANDA
Marketing start 2002-04-22
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075803-001 LESSINA-21 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 A075803-002 LESSINA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075803-002 AB2
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 3 · 86 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 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075803-001 LESSINA-21 0.02MG;0.1MG TABLET / ORAL-21 2002-03-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075803-002 LESSINA-28 0.02MG;0.1MG TABLET / ORAL-28 AB2 2002-03-20 74a2ff9319b5…
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 Lessina
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242297 Internal RxNorm lookup 748797 Internal RxNorm lookup 748868 Internal RxNorm lookup 751885 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0555-9014-67 Lessina 3 in 1 CARTON KIT 3 10 0555-9014-79 Lessina 1 in 1 POUCH KIT 1 10 0555-9014-79 Lessina 1 in 1 BLISTER PACK KIT 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-9014 LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.] 10 Current NDC, Legacy NDC, 3 package rows 20211230_a5fd1b3a-019c-4871-95b3-a45bbbd46f82.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 Lessina LEVONORGESTREL AND ETHINYL ESTRADIOL Teva Pharmaceuticals USA, Inc. a5fd1b3a-019c-4871-95b3-a45bbbd46f82 2021-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075803 application number: ANDA075803 ndc (product): 0555-9014
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 0555-9014-67 00555901467 3 POUCH in 1 CARTON (0555-9014-67) / 1 BLISTER PACK in 1 POUCH (0555-9014-79) / 1 KIT in 1 BLISTER PACK 3 pouch 2002-04-22 0000-00-00 No No Current 0555-9014-79 00555901479 1 in 1 POUCH Historical