Delestrogen

Product NDC: 42023-112
11-digit product format: 420230112
Labeler code: 42023
Product ID: 42023-112_132be116-35a8-467c-8e9e-da721c2bcf0d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol valerate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Par Pharmaceutical, Inc.
Application: NDA009402
Marketing category: NDA
Marketing start: 2007-11-01
Marketing end: 0000-00-00
Substance: ESTRADIOL VALERATE
Active strength: 40 mg/mL
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42023-112		D	Discontinued by firm		2026-08-17
excluded package	package	42023-112	42023-112-01	D	Discontinued by firm		2026-08-17

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42023-112-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42023-112-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42023-112-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42023-112-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42023-112-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42023-112-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42023-112-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42023-112-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42023-112-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42023-112-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42023-112-01	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N009402-002	DELESTROGEN	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982
N009402-003	DELESTROGEN	ESTRADIOL VALERATE	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N009402-004	DELESTROGEN	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N009402-002	AO
N009402-004	AO

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009402-003	DELESTROGEN	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009402-003	DELESTROGEN	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N009402-002	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009402-004	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009402-002	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009402-004	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009402-002	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009402-004	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009402-002	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009402-004	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009402-002	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009402-004	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009402-002	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009402-004	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009402-002	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009402-004	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009402-002	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009402-004	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-002	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-003	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-004	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009402-002	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009402-004	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009402-002	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009402-004	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-002	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-003	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-004	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-002	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-003	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-004	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009402-002	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009402-003	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009402-004	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009402-002	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009402-003	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009402-004	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009402-002	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009402-003	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009402-004	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009402-002	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N009402-003	AO	1	`5d02ea3f76ae…`

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
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
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
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
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-112-01	ML - Milliliter	42023-112	ab5f5b96-4734-4805-882c-7510d83c2ca6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
estradiol valerate	ACTIVE INGREDIENT	OKG364O896	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.]	8
estradiol	ACTIVE MOIETY	4TI98Z838E	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.]	8
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.]	8
benzyl benzoate	INACTIVE INGREDIENT	N863NB338G	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.]	8
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.]	8
chlorobutanol	INACTIVE INGREDIENT	HM4YQM8WRC	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.]	8
sesame oil	INACTIVE INGREDIENT	QX10HYY4QV	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-112	DELESTROGEN (ESTRADIOL VALERATE) INJECTION [ENDO USA, INC.]	22	Legacy NDC	20240709_e8f94df9-0692-4462-a7f0-fe019a0a3f07.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
Delestrogen	ESTRADIOL VALERATE	Par Health USA, LLC	e8f94df9-0692-4462-a7f0-fe019a0a3f07	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 009402 application number: NDA009402

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OKG364O896	ESTRADIOL VALERATE	979-32-8	ESTRADIOL VALERATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
206620	DELESTROGEN 10 MG/ML Injectable Solution	PSN	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
206715	DELESTROGEN 20 MG/ML Injectable Solution	PSN	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
310189	estradiol valerate 10 MG/ML Injectable Solution	PSN	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
310190	estradiol valerate 20 MG/ML Injectable Solution	PSN	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
206620	estradiol valerate 10 MG/ML Injectable Solution [Delestrogen]	SBD	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
206715	estradiol valerate 20 MG/ML Injectable Solution [Delestrogen]	SBD	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
310189	estradiol valerate 10 MG/ML Injectable Solution	SCD	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
310190	estradiol valerate 20 MG/ML Injectable Solution	SCD	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
206620	Delestrogen 10 MG/ML Injectable Solution	SY	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29
206715	Delestrogen 20 MG/ML Injectable Solution	SY	e8f94df9-0692-4462-a7f0-fe019a0a3f07	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-112-01	42023011201	5 mL in 1 VIAL, MULTI-DOSE (42023-112-01)	5 ml	2007-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DELESTROGEN ® (estradiol valerate injection, USP)	Par Health USA, LLC	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	29