Home NDC 65862-865 Iclevia
Product NDC 65862-865
11-digit product format 658620865
Labeler code 65862
Product ID 65862-865_e44389c6-fdd2-408e-8bfe-324842c36d76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form KIT
Labeler Aurobindo Pharma Limited
Application ANDA206850
Marketing category ANDA
Marketing start 2018-06-29
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 A206850-001 ICLEVIA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206850-001 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 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206850-001 ICLEVIA 0.03MG;0.15MG TABLET / ORAL AB 2018-06-29 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 Iclevia
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 238019 Internal RxNorm lookup 748797 Internal RxNorm lookup 751901 Internal RxNorm lookup 2049264 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 65862-865-83 Iclevia 3 in 1 CARTON KIT 3 9 65862-865-94 Iclevia 1 in 1 POUCH KIT 1 9 65862-865-94 Iclevia 1 in 1 BLISTER PACK KIT 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-865 ICLEVIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED] 9 Current NDC, Legacy NDC, 3 package rows 20240805_00657f4e-9df8-4f58-91a0-eff5a467f988.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 Iclevia LEVONORGESTREL AND ETHINYL ESTRADIOL Aurobindo Pharma Limited 00657f4e-9df8-4f58-91a0-eff5a467f988 2024-07-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206850 application number: ANDA206850 ndc (product): 65862-865
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 65862-865-83 65862086583 3 POUCH in 1 CARTON (65862-865-83) / 1 BLISTER PACK in 1 POUCH (65862-865-94) / 1 KIT in 1 BLISTER PACK 3 pouch 2018-06-29 0000-00-00 No No Current 65862-865-94 65862086594 1 in 1 POUCH Historical