Bijuva

Product NDC: 50261-211
11-digit product format: 502610211
Labeler code: 50261
Product ID: 50261-211_fca91f4b-94dd-41c9-90c3-c50c4b2dcd76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol and progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma LLC
Application: NDA210132
Marketing category: NDA
Marketing start: 2019-04-03
Substance: ESTRADIOL; PROGESTERONE
Active strength: 1; 100 mg/1; mg/1
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50261-211		I	Inactivated by FDA	2026-08-03
excluded package	package	50261-211	50261-211-05	I	Inactivated by FDA	2026-08-03
excluded package	package	50261-211	50261-211-30	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 · 7 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210132-001	BIJUVA	ESTRADIOL; PROGESTERONE	1MG;100MG	CAPSULE / ORAL		RLD, RS	2018-10-28
N210132-002	BIJUVA	ESTRADIOL; PROGESTERONE	0.5MG;100MG	CAPSULE / ORAL		RLD	2021-12-28

Orange Book patents#

Current patent rows page 1 of 1 · 39 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210132-001	10052386	2032-11-21		Drug product	2018-11-19
N210132-001	10206932	2032-11-21	U-2439		2019-03-11
N210132-001	10639375	2032-11-21		Drug product	2020-05-12
N210132-001	10675288	2032-11-21	U-2439		2020-06-10
N210132-001	10806740	2032-11-21	U-2439	Drug product	2020-10-30
N210132-001	11033626	2032-11-21	U-2439	Drug product	2021-07-13
N210132-001	11103513	2032-11-21	U-2439		2021-09-23
N210132-001	11103516	2032-11-21		Drug product	2021-09-23
N210132-001	11110099	2032-11-21		Drug product	2021-09-23
N210132-001	11529360	2032-11-21		Drug product	2022-12-21
N210132-001	11793819	2032-11-21	U-2439		2023-11-14
N210132-001	11865179	2032-11-21		Drug substance, Drug product	2024-02-01
N210132-001	8633178	2032-11-21		Drug product	2018-11-19
N210132-001	8846648	2032-11-21	U-2439		2018-11-19
N210132-001	8846649	2032-11-21	U-2439	Drug product	2018-11-19
N210132-001	8987237	2032-11-21		Drug product	2018-11-19
N210132-001	8993548	2032-11-21		Drug product	2018-11-19
N210132-001	8993549	2032-11-21		Drug product	2018-11-19
N210132-001	9006222	2032-11-21	U-2439	Drug product	2018-11-19
N210132-001	9114145	2032-11-21	U-2439		2018-11-19
N210132-001	9114146	2032-11-21	U-2439	Drug product	2018-11-19
N210132-001	9301920	2032-11-21	U-2439	Drug product	2018-11-19
N210132-002	10052386	2032-11-21		Drug product	2022-01-26
N210132-002	10206932	2032-11-21	U-2439		2022-01-26
N210132-002	10675288	2032-11-21	U-2439		2022-01-26
N210132-002	11033626	2032-11-21	U-2439	Drug product	2022-01-26
N210132-002	11166963	2032-11-21		Drug product	2022-01-26
N210132-002	11793819	2032-11-21	U-2439		2023-11-14
N210132-002	11865179	2032-11-21		Drug substance, Drug product	2024-02-01
N210132-002	8633178	2032-11-21		Drug product	2022-01-26
N210132-002	8846648	2032-11-21	U-2439		2022-01-26
N210132-002	8846649	2032-11-21	U-2439	Drug product	2022-01-26
N210132-002	8933059	2032-11-21	U-2439	Drug product	2022-01-26
N210132-002	8987237	2032-11-21		Drug product	2022-01-26
N210132-002	8993548	2032-11-21		Drug product	2022-01-26
N210132-002	8993549	2032-11-21		Drug product	2022-01-26
N210132-002	9114145	2032-11-21	U-2439		2022-01-26
N210132-002	9114146	2032-11-21	U-2439	Drug product	2022-01-26
N210132-002	9301920	2032-11-21	U-2439	Drug product	2022-01-26

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 · 73 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	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210132-002	BIJUVA	0.5MG;100MG	CAPSULE / ORAL	RLD	2021-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210132-001	BIJUVA	1MG;100MG	CAPSULE / ORAL	RLD, RS	2018-10-28	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,308 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	N210132-001	10052386	2032-11-21		Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	10206932	2032-11-21	U-2439		2019-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	10639375	2032-11-21		Drug product	2020-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	10675288	2032-11-21	U-2439		2020-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	10806740	2032-11-21	U-2439	Drug product	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	11033626	2032-11-21	U-2439	Drug product	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	11103513	2032-11-21	U-2439		2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	11103516	2032-11-21		Drug product	2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	11110099	2032-11-21		Drug product	2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	11529360	2032-11-21		Drug product	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	11793819	2032-11-21	U-2439		2023-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	11865179	2032-11-21		Drug substance, Drug product	2024-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	8633178	2032-11-21		Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	8846648	2032-11-21	U-2439		2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	8846649	2032-11-21	U-2439	Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	8987237	2032-11-21		Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	8993548	2032-11-21		Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	8993549	2032-11-21		Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	9006222	2032-11-21	U-2439	Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	9114145	2032-11-21	U-2439		2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	9114146	2032-11-21	U-2439	Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-001	9301920	2032-11-21	U-2439	Drug product	2018-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	10052386	2032-11-21		Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	10206932	2032-11-21	U-2439		2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	10675288	2032-11-21	U-2439		2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	11033626	2032-11-21	U-2439	Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	11166963	2032-11-21		Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	11793819	2032-11-21	U-2439		2023-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	11865179	2032-11-21		Drug substance, Drug product	2024-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	8633178	2032-11-21		Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	8846648	2032-11-21	U-2439		2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	8846649	2032-11-21	U-2439	Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	8933059	2032-11-21	U-2439	Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	8987237	2032-11-21		Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	8993548	2032-11-21		Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	8993549	2032-11-21		Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	9114145	2032-11-21	U-2439		2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	9114146	2032-11-21	U-2439	Drug product	2022-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210132-002	9301920	2032-11-21	U-2439	Drug product	2022-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210132-001	10052386	2032-11-21		Drug product	2018-11-19	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N210132-001	NP	2021-10-28	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N210132-001	NP	2021-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210132-001	NP	2021-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210132-001	NP	2021-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210132-001	NP	2021-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210132-001	NP	2021-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210132-001	NP	2021-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210132-001	NP	2021-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210132-001	NP	2021-10-28	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
b46148e2-ee15-98d5-12f0-f5ec8745f6fc	Product name	3	20220927
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
d3229c1a-4e51-4e04-9b13-00d24fd35242	Product name	1	20200821
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
213f0591-95c1-b398-40b7-08b31f66b026	Product name	4	20190206
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
85b2d644-53b2-f2dc-4dbc-859116ce56c0	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aac	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50261-211-05	Bijuva	1 in 1 CARTON	CAPSULE	1	13
50261-211-05	Bijuva	5 in 1 BLISTER PACK	CAPSULE	5	13
50261-211-30	Bijuva	1 in 1 CARTON	CAPSULE	1	13
50261-211-30	Bijuva	30 in 1 BLISTER PACK	CAPSULE	30	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50261-211-30	EA - Each	50261-211	a6d0594b-bb66-486d-8800-7a5075097f8b	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50261-211	BIJUVA (ESTRADIOL AND PROGESTERONE) CAPSULE [MAYNE PHARMA LLC]	11	Current NDC, Legacy NDC, 4 package rows	20250130_bc52489a-5149-411d-9665-2c75405ad15d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL
4G7DS2Q64Y	PROGESTERONE	57-83-0	PROGESTERONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2632846	Bijuva 0.5 MG / 100 MG Oral Capsule	PSN	bc52489a-5149-411d-9665-2c75405ad15d	13
2108930	Bijuva 1 MG / 100 MG Oral Capsule	PSN	bc52489a-5149-411d-9665-2c75405ad15d	13
2632844	estradiol 0.5 MG / progesterone 100 MG Oral Capsule	PSN	bc52489a-5149-411d-9665-2c75405ad15d	13
2108924	estradiol 1 MG / progesterone 100 MG Oral Capsule	PSN	bc52489a-5149-411d-9665-2c75405ad15d	13
2632846	estradiol 0.5 MG / progesterone 100 MG Oral Capsule [Bijuva]	SBD	bc52489a-5149-411d-9665-2c75405ad15d	13
2108930	estradiol 1 MG / progesterone 100 MG Oral Capsule [Bijuva]	SBD	bc52489a-5149-411d-9665-2c75405ad15d	13
2632844	estradiol 0.5 MG / progesterone 100 MG Oral Capsule	SCD	bc52489a-5149-411d-9665-2c75405ad15d	13
2108924	estradiol 1 MG / progesterone 100 MG Oral Capsule	SCD	bc52489a-5149-411d-9665-2c75405ad15d	13
2632846	Bijuva (estradiol 0.5 MG / progesterone 100 MG) Oral Capsule	SY	bc52489a-5149-411d-9665-2c75405ad15d	13
2108930	Bijuva (estradiol 1 MG / progesterone 100 MG) Oral Capsule	SY	bc52489a-5149-411d-9665-2c75405ad15d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50261-211-05	50261021105	1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK	1 blister pack	2019-04-03	0000-00-00	Yes	No	Current
50261-211-30	50261021130	1 BLISTER PACK in 1 CARTON (50261-211-30) > 30 CAPSULE in 1 BLISTER PACK	1 blister pack	2019-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bijuva	Mayne Pharma LLC \| Catalent Pharma Solutions LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	13