Estradiol

Product NDC: 69761-010
11-digit product format: 697610010
Labeler code: 69761
Product ID: 69761-010_a9ee28a3-5d47-44e5-af37-3c24287e4a8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: PELLET
Route: ORAL
Labeler: Qualgen LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2015-09-01
Marketing end: 0000-00-00
Substance: ESTRADIOL
Active strength: 10 mg/1
Pharmacologic classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69761-010		D	Discontinued by firm		2026-10-05
excluded package	package	69761-010	69761-010-12	D	Discontinued by firm		2026-10-05
excluded package	package	69761-010	69761-010-30	D	Discontinued by firm		2026-10-05
compounder	package	69761-010	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2021-2	2026-10-06
compounder	package	69761-010	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2021-1	2026-10-06
compounder	package	69761-010	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2020-2	2026-10-06
compounder	package	69761-010	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2020-1	2026-10-06
compounder	package	69761-010	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2019-2	2026-10-06
compounder	package	69761-010	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2019-1	2026-10-06

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:00 UTC · source 2025-08-20	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2021-2	compounder / compounders_ndc_directory.zip	`af8e9b524e63…`	`ca326a94a5e9…`
2025-08-27 00:00 UTC · source 2025-08-20	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2021-1	compounder / compounders_ndc_directory.zip	`af8e9b524e63…`	`ca326a94a5e9…`
2025-08-27 00:00 UTC · source 2025-08-20	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2020-2	compounder / compounders_ndc_directory.zip	`af8e9b524e63…`	`ca326a94a5e9…`
2025-08-27 00:00 UTC · source 2025-08-20	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2020-1	compounder / compounders_ndc_directory.zip	`af8e9b524e63…`	`ca326a94a5e9…`
2025-08-27 00:00 UTC · source 2025-08-20	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2019-2	compounder / compounders_ndc_directory.zip	`af8e9b524e63…`	`ca326a94a5e9…`
2025-08-27 00:00 UTC · source 2025-08-20	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2019-1	compounder / compounders_ndc_directory.zip	`af8e9b524e63…`	`ca326a94a5e9…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69761-010-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69761-010-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-05-13 07:20 UTC · source 2022-04-19	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2021-2	compounder / compounders_ndc_directory.zip	`4694734df12d…`	`db2bf3a0aaab…`
2022-05-13 07:20 UTC · source 2022-04-19	compounder	package	69761-010-01	COMPOUNDER	Outsourcing facility compounded drug report	2021-1	compounder / compounders_ndc_directory.zip	`4694734df12d…`	`db2bf3a0aaab…`

Compounder NDC reports#

Browse the complete compounder directory for this NDC · Browse every current compounder row in the unified auxiliary catalog · browse compounder source captures and parsed snapshots.

Establishment, FEI, Product NDC table
Establishment	FEI	Product NDC	Package NDC	Product	Active ingredients	Reporting period	Normalization
Qualgen LLC	034474862	69761-010	69761-010-01	Estradiol	10 mg	2021-2	valid
Qualgen LLC	034474862	69761-010	69761-010-01	Estradiol	10 mg	2021-1	valid
Qualgen LLC	034474862	69761-010	69761-010-01	Estradiol	10 mg	2020-2	valid
Qualgen LLC	034474862	69761-010	69761-010-01	Estradiol	10 mg	2020-1	valid
Qualgen LLC	034474862	69761-010	69761-010-01	Estradiol	10 mg	2019-2	valid
Qualgen LLC	034474862	69761-010	69761-010-01	Estradiol	10 mg	2019-1	valid

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTRADIOL PELLET [QUALGEN LLC]	1
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL PELLET [QUALGEN LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ESTRADIOL PELLET [QUALGEN LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69761-010-12	69761001012	12 PELLET in 1 PACKAGE (69761-010-12)	12 pellet	2015-09-01	0000-00-00	No	No	Current
69761-010-30	69761001030	30 PELLET in 1 PACKAGE (69761-010-30)	30 pellet	2015-09-01	0000-00-00	No	No	Current