Skyla

Product NDC: 50419-422
11-digit product format: 504190422
Labeler code: 50419
Product ID: 50419-422_01b52e09-d273-4503-8589-a2bb64c1574c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levonorgestrel
Dosage form: INTRAUTERINE DEVICE
Route: INTRAUTERINE
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA203159
Marketing category: NDA
Marketing start: 2013-01-11
Substance: LEVONORGESTREL
Active strength: 13.5 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: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50419-422	50419-422-71	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
N203159-001	SKYLA	LEVONORGESTREL	13.5MG	SYSTEM / INTRAUTERINE		RLD, RS	2013-01-09

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203159-001	11628088	2027-02-07		Drug product	2023-08-24
N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29
N203159-001	10561524	2029-09-16	U-2948		2020-09-28

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	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203159-001	SKYLA	13.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2013-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203159-001	SKYLA	13.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2013-01-09	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 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	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203159-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203159-001	10561524	2029-09-16	U-2948		2020-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203159-001	11628088	2027-02-07		Drug product	2023-08-24	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Skyla
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVONORGESTREL	13.5 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
1366334	Internal RxNorm lookup
1366339	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9f44ff35-e052-49cd-a1c2-0bfd87d49309	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1	Product name	1	20201123
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
85bed648-23ca-4804-98e6-e36aee999cad	Product name	1	20190717
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
f713a022-3e1c-4035-bc91-62131bc80b42	Product name	2	20190125
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
80de93b4-8a94-428d-beb7-d644353ee70b	Product name	1	20180424
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688	Product name	1	20170522
db8eb201-78c7-4590-8a71-fac0a539bd8c	Product name	1	20170404
141092be-5eb5-452e-9f69-2d350aa70a87	Product name	1	20161208
741e98f2-ac6c-4d80-9ca8-c663c171ba1d	Product name	1	20161121
cc765024-f257-4c67-b780-c356aadd6980	Product name	3	20150902
5a9b579b-8431-5b3a-2ba4-86556704f873	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
d03a75af-b11b-673b-268b-318050d0b3bd	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508
e5ccd419-1745-560a-1e25-c6e3941c710a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50419-422-01	Skyla	1 in 1 CARTON	INTRAUTERINE DEVICE	1	22
50419-422-08	Skyla	1 in 1 CARTON	INTRAUTERINE DEVICE	1	22
50419-422-71	Skyla	1 in 1 CARTON	INTRAUTERINE DEVICE	1	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-422-01	EA - Each	50419-422	68276b4c-f515-4a28-90b0-4ffb4df33213	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]	7
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]	7
BARIUM SULFATE	INACTIVE INGREDIENT	25BB7EKE2E	SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]	7
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-422	SKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]	19	Current NDC, Legacy NDC, 3 package rows	20241207_9f44ff35-e052-49cd-a1c2-0bfd87d49309.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
Skyla	LEVONORGESTREL	Bayer HealthCare Pharmaceuticals Inc.	9f44ff35-e052-49cd-a1c2-0bfd87d49309	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203159 application number: NDA203159 ndc (product): 50419-422

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5W7SIA7YZW	LEVONORGESTREL	797-63-7	LEVONORGESTREL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1366334	levonorgestrel 13.5 MG Intrauterine System	PSN	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366339	Skyla 13.5 MG Intrauterine System	PSN	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366339	levonorgestrel 0.000583 MG/HR Intrauterine System [Skyla]	SBD	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366334	levonorgestrel 0.000583 MG/HR Intrauterine System	SCD	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366334	levonorgestrel 13.5 MG Intrauterine System	SY	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366334	levonorgestrel 14 MCG per 24 HR Intrauterine System	SY	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366339	Skyla 0.000583 MG/HR Intrauterine System	SY	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366339	Skyla 13.5 MG Intrauterine System	SY	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22
1366339	Skyla 14 MCG per 24HR Intrauterine System	SY	9f44ff35-e052-49cd-a1c2-0bfd87d49309	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50419-422-01	50419042201	1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)	1 intrauterine device	2013-01-11	0000-00-00	No	No	Current
50419-422-08	50419042208	1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)	1 intrauterine device	2013-01-11	0000-00-00	No	No	Current
50419-422-71	50419042271	1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-71)	1 intrauterine device	2013-01-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Skyla - Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	22