Tri-VyLibra Lo

Product NDC: 53002-1778
Requested package NDC: 53002-1778-1
11-digit product format: 530021778
Labeler code: 53002
Product ID: 53002-1778_e31e08ca-2295-4612-81cd-3edd67c67488
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norgestimate and Ethinyl Estradiol
Dosage form: KIT
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA205762
Marketing category: ANDA
Marketing start: 2016-11-04
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1778	53002-1778-1	I	Inactivated by FDA		2026-08-11

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A205762-001	TRI-LO-MILI	ETHINYL ESTRADIOL; NORGESTIMATE	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB		2016-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205762-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205762-001	TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	TABLET / ORAL-28	AB	2016-11-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205762-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205762-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205762-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205762-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205762-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205762-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205762-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205762-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205762-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205762-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205762-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205762-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205762-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205762-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205762-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205762-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205762-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205762-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205762-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205762-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205762-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205762-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205762-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205762-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205762-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205762-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205762-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205762-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205762-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205762-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205762-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205762-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205762-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205762-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205762-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205762-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205762-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205762-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205762-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205762-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-1778-1	2025-01-30	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-3	2025-01-30	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-6	2025-01-30	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-1	2023-06-07	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-3	2023-06-07	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-6	2023-06-07	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-1	2023-01-30	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-3	2023-01-30	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
53002-1778-6	2023-01-30	These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1778-1	Tri-VyLibra Lo	1 in 1 BLISTER PACK	KIT	1	4
53002-1778-3	Tri-VyLibra Lo	3 in 1 POUCH	KIT	3	4
53002-1778-3	Tri-VyLibra Lo	1 in 1 BLISTER PACK	KIT	1	4
53002-1778-6	Tri-VyLibra Lo	6 in 1 POUCH	KIT	6	4
53002-1778-6	Tri-VyLibra Lo	1 in 1 BLISTER PACK	KIT	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1778	TRI-VYLIBRA LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.]	4	Legacy NDC, 5 package rows	20230609_afdd0fea-eadb-4c40-b5a6-a74a5c3262a3.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tri-VyLibra Lo	NORGESTIMATE AND ETHINYL ESTRADIOL	Afaxys Pharma, LLC	bd51a08e-cd45-4315-9bca-41794450ef16	2023-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205762 application number: ANDA205762
Tri-Lo-Mili	NORGESTIMATE AND ETHINYL ESTRADIOL	Proficient Rx LP	5f3dedb9-a500-4e21-8ffa-0d942243c790	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205762 application number: ANDA205762
Tri-Lo-Mili	NORGESTIMATE AND ETHINYL ESTRADIOL	Aurobindo Pharma Limited	d9d2d0a1-b336-40ee-b4cc-b3d876ca91b9	2022-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205762 application number: ANDA205762

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2104192	{7 (ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Tri-VyLibra Lo 28 Day]	BPCK	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749157	{7 (ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749157	eth estra-norgestim 0.025-0.18 MG (7) Oral Tablet / eth estra-norgestim 0.025-0.215 MG (7) Oral Tablet / eth estra-norgestim 0.025-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
748797	inert 1 MG Oral Tablet	PSN	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
578732	norgestimate 0.18 MG / ethinyl estradiol 0.025 MG Oral Tablet	PSN	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749155	norgestimate 0.215 MG / ethinyl estradiol 0.025 MG Oral Tablet	PSN	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749156	norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet	PSN	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
2104192	Tri-VyLibra Lo 28 Day Pack	PSN	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
578732	ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet	SCD	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749155	ethinyl estradiol 0.025 MG / norgestimate 0.215 MG Oral Tablet	SCD	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749156	ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet	SCD	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
748797	inert ingredients 1 MG Oral Tablet	SCD	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
578732	ethinyl estradiol 25 MCG / norgestimate 180 MCG Oral Tablet	SY	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749155	ethinyl estradiol 25 MCG / norgestimate 215 MCG Oral Tablet	SY	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
749156	ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet	SY	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4
2104192	Tri-VyLibra Lo 28 Day Pack	SY	afdd0fea-eadb-4c40-b5a6-a74a5c3262a3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1778-1	53002177801	1 KIT in 1 BLISTER PACK (53002-1778-1)	1 kit	2019-01-01	0000-00-00	No	No	Current