levonorgestrel and ethinyl estradiol

Product NDC: 42192-623
11-digit product format: 421920623
Labeler code: 42192
Product ID: 42192-623_18a7ed1f-bfc1-476c-9550-77f80f5feeac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levonorgestrel and ethinyl estradiol
Dosage form: KIT
Labeler: Acella Pharmaceuticals
Application: NDA208612
Marketing category: NDA
Marketing start: 2023-08-21
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 42.

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
N208612-001	BALCOLTRA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208612-001	AB3

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30

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 · 42 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
2026-08-18 06:07:40	2026-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL			2018-01-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL	AB3	RLD, RS	2018-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208612-001	BALCOLTRA	0.02MG;0.1MG	TABLET / ORAL		RLD, RS	2018-01-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N208612-001	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208612-001	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208612-001	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208612-001	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208612-001	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208612-001	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208612-001	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208612-001	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208612-001	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208612-001	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208612-001	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208612-001	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208612-001	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208612-001	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208612-001	AB3	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208612-001	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208612-001	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208612-001	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208612-001	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208612-001	AB3	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208612-001	AB3	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208612-001	6716814	2021-08-16		Drug substance, Drug product	2018-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208612-001	7838042	2027-06-01	U-3251	Drug substance	2021-11-30	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: levonorgestrel and ethinyl estradiol
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242297	Internal RxNorm lookup
2672922	Internal RxNorm lookup
2672923	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
167b12a0-cdff-4081-a0a4-164482c239fa	Available on FDA.report

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
f713a022-3e1c-4035-bc91-62131bc80b42	Product name	2	20190125
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
741e98f2-ac6c-4d80-9ca8-c663c171ba1d	Product name	1	20161121
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
cc765024-f257-4c67-b780-c356aadd6980	Product name	3	20150902
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
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d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
42192-623-03	2023-08-25	These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS safely and effectively. See Full Prescribing Information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets and FERROUS BISGLYCINATE tablets for oral administration Initial U.S. Approval: 1997
42192-623-28	2023-08-25	These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS safely and effectively. See Full Prescribing Information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets and FERROUS BISGLYCINATE tablets for oral administration Initial U.S. Approval: 1997
42192-623-03	2023-01-30	These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS safely and effectively. See Full Prescribing Information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets and FERROUS BISGLYCINATE tablets for oral administration Initial U.S. Approval: 1997
42192-623-28	2023-01-30	These highlights do not include all the information needed to use LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS safely and effectively. See Full Prescribing Information for LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND FERROUS BISGLYCINATE TABLETS. LEVONORGESTREL and ETHINYL ESTRADIOL tablets and FERROUS BISGLYCINATE tablets for oral administration Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42192-623-03	levonorgestrel and ethinyl estradiol	3 in 1 CARTON	KIT	3	5
42192-623-03	levonorgestrel and ethinyl estradiol	1 in 1 BLISTER PACK	KIT	1	5
42192-623-28	levonorgestrel and ethinyl estradiol	1 in 1 BLISTER PACK	KIT	1	5
42192-623-28	levonorgestrel and ethinyl estradiol	1 in 1 CARTON	KIT	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42192-623-03	EA - Each	42192-623	67f9aa26-ab9a-47b2-8fae-8fa92750db1f	1	2023-09-05
42192-623-28	EA - Each	42192-623	94a8e795-f5c5-4661-a269-38eed29a2ba7	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42192-623	LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [ACELLA PHARMACEUTICALS]	4	Current NDC, Legacy NDC, 4 package rows	20231130_167b12a0-cdff-4081-a0a4-164482c239fa.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levonorgestrel and ethinyl estradiol	LEVONORGESTREL AND ETHINYL ESTRADIOL	Acella Pharmaceuticals	167b12a0-cdff-4081-a0a4-164482c239fa	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208612 application number: NDA208612 ndc (product): 42192-623
Balcoltra	LEVONORGESTREL AND ETHINYL ESTRADIOL	Avion Pharmaceuticals	752ab698-4b48-4614-8016-d1d33ee7c007	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208612 application number: NDA208612

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2672923	{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack	GPCK	167b12a0-cdff-4081-a0a4-164482c239fa	5
2672923	Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack	PSN	167b12a0-cdff-4081-a0a4-164482c239fa	5
2672922	ferrous bisglycinate 36.5 MG Oral Tablet	PSN	167b12a0-cdff-4081-a0a4-164482c239fa	5
242297	levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet	PSN	167b12a0-cdff-4081-a0a4-164482c239fa	5
242297	ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet	SCD	167b12a0-cdff-4081-a0a4-164482c239fa	5
2672922	ferrous bisglycinate 36.5 MG Oral Tablet	SCD	167b12a0-cdff-4081-a0a4-164482c239fa	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42192-623-03	42192062303	3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK	3 blister pack	2023-08-21	0000-00-00	No	No	Current
42192-623-28	42192062328	1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK	1 blister pack	2023-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
levonorgestrel and ethinyl estradiol	Acella Pharmaceuticals \| Novast Laboratories, Ltd.	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	5