Nextstellis

Product NDC: 51862-258
11-digit product format: 518620258
Labeler code: 51862
Product ID: 51862-258_cb3d0738-1ec9-47a9-9167-8a4eb905ddab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: drospirenone and estetrol
Dosage form: KIT
Labeler: Mayne Pharma
Application: NDA214154
Marketing category: NDA
Marketing start: 2021-04-16
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
N214154-001	NEXTSTELLIS	DROSPIRENONE; ESTETROL	3MG;14.2MG	TABLET / ORAL		RLD, RS	2021-04-15

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30
N214154-001	11793760	2036-06-17		Drug product	2023-10-31
N214154-001	11957694	2036-06-17		Drug product	2024-04-29
N214154-001	11964055	2036-06-17		Drug product	2024-04-29
N214154-001	12427114	2036-06-17	U-3152	Drug product	2025-10-16
N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06
N214154-001	12458649	2043-10-01	U-3152		2025-11-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214154-001	NCE	2026-04-15

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.

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	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214154-001	NEXTSTELLIS	3MG;14.2MG	TABLET / ORAL	RLD, RS	2021-04-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 93 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	N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	12427114	2036-06-17	U-3152	Drug product	2025-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214154-001	12458649	2043-10-01	U-3152		2025-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	12427114	2036-06-17	U-3152	Drug product	2025-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	12458649	2043-10-01	U-3152		2025-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214154-001	7732430	2028-01-15	U-3152	Drug product	2021-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	12233074	2043-02-09	U-3152	Drug product	2025-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	7732430	2026-03-02	U-3152	Drug product	2021-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	7732430	2025-03-02	U-3152	Drug product	2021-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	11793760	2036-06-17		Drug product	2023-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	11957694	2036-06-17		Drug product	2024-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	11964055	2036-06-17		Drug product	2024-04-29	`5bbf6a4d5a75…`

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	N214154-001	NCE	2026-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214154-001	NCE	2026-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214154-001	NCE	2026-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214154-001	NCE	2026-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214154-001	NCE	2026-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214154-001	NCE	2026-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214154-001	NCE	2026-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214154-001	NCE	2026-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214154-001	NCE	2026-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214154-001	NCE	2026-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214154-001	NCE	2026-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214154-001	NCE	2026-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214154-001	NCE	2026-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214154-001	NCE	2026-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214154-001	NCE	2026-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214154-001	NCE	2026-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214154-001	NCE	2026-04-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214154-001	NCE	2026-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214154-001	NCE	2026-04-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214154-001	NCE	2026-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214154-001	NCE	2026-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214154-001	NCE	2026-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214154-001	NCE	2026-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214154-001	NCE	2026-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214154-001	NCE	2026-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214154-001	NCE	2026-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214154-001	NCE	2026-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214154-001	NCE	2026-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214154-001	NCE	2026-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214154-001	NCE	2026-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214154-001	NCE	2026-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214154-001	NCE	2026-04-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214154-001	NCE	2026-04-15	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nextstellis
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
748797	Internal RxNorm lookup
2539032	Internal RxNorm lookup
2539033	Internal RxNorm lookup
2539036	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
c5270073-d083-4109-ae4b-156986175e0a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94cad6dc-cea3-446b-a918-06fd714373a6	Product name	1	20211018
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
89f15567-66a7-42ff-8abb-567b85d302d8	Product name	1	20190828
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51862-258-00	Nextstellis	1 in 1 BLISTER PACK	KIT	1		7
51862-258-00	Nextstellis	1 in 1 CARTON	KIT	1		7
51862-258-01	Nextstellis	1 in 1 BLISTER PACK	KIT	1		7
51862-258-01	Nextstellis	1 in 1 CARTON	KIT	1		7
51862-259-24	Nextstellis	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	3 mg	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-258-01	EA - Each	51862-258	a21ed1b0-ece1-457c-a558-81da2ae39be9	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-258	NEXTSTELLIS (DROSPIRENONE AND ESTETROL) KIT [MAYNE PHARMA]	7	Current NDC, Legacy NDC, 5 package rows	20230804_c5270073-d083-4109-ae4b-156986175e0a.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
Nextstellis	DROSPIRENONE AND ESTETROL	Mayne Pharma	c5270073-d083-4109-ae4b-156986175e0a	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214154 application number: NDA214154 ndc (product): 51862-258

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2539032	{24 (drospirenone 3 MG / estetrol 14.2 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack [Nextstellis 28 Day]	BPCK	c5270073-d083-4109-ae4b-156986175e0a	7
2539036	{24 (drospirenone 3 MG / estetrol 14.2 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	c5270073-d083-4109-ae4b-156986175e0a	7
2539036	drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack	PSN	c5270073-d083-4109-ae4b-156986175e0a	7
2539033	drospirenone 3 MG / estetrol 14.2 MG Oral Tablet	PSN	c5270073-d083-4109-ae4b-156986175e0a	7
748797	inert 1 MG Oral Tablet	PSN	c5270073-d083-4109-ae4b-156986175e0a	7
2539032	Nextstellis 28 Day Pack	PSN	c5270073-d083-4109-ae4b-156986175e0a	7
2539033	drospirenone 3 MG / estetrol 14.2 MG Oral Tablet	SCD	c5270073-d083-4109-ae4b-156986175e0a	7
748797	inert ingredients 1 MG Oral Tablet	SCD	c5270073-d083-4109-ae4b-156986175e0a	7
2539032	Nextstellis 28 Day Pack	SY	c5270073-d083-4109-ae4b-156986175e0a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-258-00	51862025800	1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)	1 blister pack	2021-04-16	0000-00-00	Yes	No	Current
51862-258-01	51862025801	1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)	1 blister pack	2021-04-16	0000-00-00	No	No	Current
51862-259-24	51862025924	24 in 1 BLISTER PACK						Historical