LILETTA

Product NDC: 52544-035
11-digit product format: 525440035
Labeler code: 52544
Product ID: 52544-035_683aabaa-6ab7-4d24-aeb2-e1e2bf4fece0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levonorgestrel
Dosage form: INTRAUTERINE DEVICE
Route: INTRAUTERINE
Labeler: Actavis Pharma, Inc.
Application: NDA206229
Marketing category: NDA
Marketing start: 2015-02-26
Marketing end: 2020-01-31
Substance: LEVONORGESTREL
Active strength: 52 mg/1
Pharmacologic classes: Inhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52544-035		D	Discontinued by firm		2026-08-10
excluded package	package	52544-035	52544-035-54	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52544-035-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52544-035-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52544-035-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52544-035-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52544-035-54	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52544-035-54	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52544-035-54	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52544-035-54	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52544-035-54	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52544-035-54	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52544-035-54	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52544-035-54	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206229-001	I-917	2026-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206229-001	I-917	2026-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206229-001	I-917	2026-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206229-001	I-917	2026-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206229-001	I-917	2026-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206229-001	I-917	2026-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206229-001	I-917	2026-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206229-001	I-917	2026-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206229-001	I-917	2026-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206229-001	I-917	2026-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206229-001	I-917	2026-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206229-001	I-917	2026-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206229-001	I-917	2026-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206229-001	I-917	2026-06-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206229-001	I-917	2026-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206229-001	I-917	2026-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206229-001	I-917	2026-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206229-001	I-917	2026-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206229-001	I-917	2026-06-29	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206229-001	I-917	2026-06-29	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52544-035-54	EA - Each	52544-035	ab30ca8d-8c02-4289-ae42-ce8d877e74ae	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	LILETTA (LEVONORGESTREL) INTRAUTERINE DEVICE [ACTAVIS PHARMA, INC.]	2
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	LILETTA (LEVONORGESTREL) INTRAUTERINE DEVICE [ACTAVIS PHARMA, INC.]	2
BARIUM SULFATE	INACTIVE INGREDIENT	25BB7EKE2E	LILETTA (LEVONORGESTREL) INTRAUTERINE DEVICE [ACTAVIS PHARMA, INC.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LILETTA (LEVONORGESTREL) INTRAUTERINE DEVICE [ACTAVIS PHARMA, INC.]	2

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
LILETTA	LEVONORGESTREL	Allergan, Inc.	aaf0eb2a-f88a-4f26-a445-0fd30176c326	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206229 application number: NDA206229