Home NDC 65862-866 Lo Simpesse
Product NDC 65862-866
11-digit product format 658620866
Labeler code 65862
Product ID 65862-866_482c2fa6-991f-4987-b343-36652f5b7c3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol
Dosage form KIT
Labeler Aurobindo Pharma Limited
Application ANDA206852
Marketing category ANDA
Marketing start 2017-04-28
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206852-001 LO SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206852-001 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 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206852-001 LO SIMPESSE 0.02MG,0.1MG;0.01MG,N/A TABLET / ORAL AB 2017-04-28 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 Lo Simpesse
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 248310 Internal RxNorm lookup 810096 Internal RxNorm lookup 1921723 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 65862-866-94 Lo Simpesse 1 in 1 POUCH KIT 1 7 65862-866-94 Lo Simpesse 1 in 1 BLISTER PACK KIT 1 7 65862-866-95 Lo Simpesse 2 in 1 CARTON KIT 2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-866 LO SIMPESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED] 7 Current NDC, Legacy NDC, 3 package rows 20230530_74d998ca-7b30-4023-928f-a0f0551992e6.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 Lo Simpesse LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Aurobindo Pharma Limited 74d998ca-7b30-4023-928f-a0f0551992e6 2023-05-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206852 application number: ANDA206852 ndc (product): 65862-866
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 65862-866-94 65862086694 1 in 1 POUCH Historical 65862-866-95 65862086695 2 POUCH in 1 CARTON (65862-866-95) / 1 BLISTER PACK in 1 POUCH (65862-866-94) / 1 KIT in 1 BLISTER PACK 2 pouch 2017-04-28 0000-00-00 No No Current