Home NDC 0023-5858 LILETTA
Product NDC 0023-5858
11-digit product format 000235858
Labeler code 0023
Product ID 0023-5858_2bd36b89-e6f6-4da1-97c4-3516f2a06b73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel
Dosage form INTRAUTERINE DEVICE
Route INTRAUTERINE
Labeler Allergan, Inc.
Application NDA206229
Marketing category NDA
Marketing start 2016-05-31
Substance LEVONORGESTREL
Active strength 52 mg/1
Pharmacologic classes Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
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 1 .
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 N206229-001 LILETTA LEVONORGESTREL 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 N206229-001 11571328 2040-09-07 Drug product 2023-02-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206229-001 I-917 2026-06-29
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 110 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 d06236e962d9…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base LILETTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVONORGESTREL 52 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5W7SIA7YZW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1605252 Internal RxNorm lookup 1605257 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 0023-5858-01 LILETTA 1 in 1 CARTON INTRAUTERINE DEVICE 1 22 0023-5858-01 LILETTA 1 in 1 TRAY INTRAUTERINE DEVICE 1 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-5858 LILETTA (LEVONORGESTREL) INTRAUTERINE DEVICE [ALLERGAN, INC.] 22 Current NDC, Legacy NDC, 2 package rows 20241024_aaf0eb2a-f88a-4f26-a445-0fd30176c326.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.
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 0023-5858-01 00023585801 1 TRAY in 1 CARTON (0023-5858-01) / 1 INTRAUTERINE DEVICE in 1 TRAY 1 tray 2016-05-31 0000-00-00 No No Current