Estradiol Vaginal

Product NDC: 72162-1389
11-digit product format: 721621389
Labeler code: 72162
Product ID: 72162-1389_3f3bbc65-e965-4cfb-b133-df4100964d6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: CREAM
Route: VAGINAL
Labeler: Bryant Ranch Prepack
Application: ANDA210194
Marketing category: ANDA
Marketing start: 2021-01-06
Substance: ESTRADIOL
Active strength: .1 mg/g
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A210194-001	ESTRADIOL	ESTRADIOL	0.01%	CREAM / VAGINAL	AB		2018-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210194-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB		2018-01-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A210194-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol Vaginal	ESTRADIOL	Redpharm Drug	546c168d-2a85-69b6-e063-6294a90a22ac	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	A-S Medication Solutions	0137d491-6917-4060-9b32-e0cd7b0badbb	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	67f581cb-6d77-49fc-b2f3-976e3b57dcbf	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194 ndc (product): 72162-1389
Estradiol Vaginal	ESTRADIOL	AvKARE	bb7b442d-b8c3-b7f0-e053-2a95a90a2c94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Padagis Israel Pharmaceuticals Ltd	f76232ed-b109-43d1-bf2e-d41b6420c37d	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	f3806b5d-ebd6-43b4-adfa-a1fe86d80642	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	NuCare Pharmaceuticals, Inc.	2e5a4d78-6683-4fb8-e063-6294a90a49e7	2025-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	e7b15ec3-e195-44a6-bdd7-9b6de2b235b8	2024-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194

Additional Listing Data#

Finished product: Yes
Brand name base: Estradiol Vaginal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4TI98Z838E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310169	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
67f581cb-6d77-49fc-b2f3-976e3b57dcbf	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-1389-2	Estradiol Vaginal	1 in 1 CARTON	CREAM	1		105
72162-1389-2	Estradiol Vaginal	42.5 g in 1 TUBE	CREAM	42.5		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1389-2	GM - Gram	72162-1389	e23043d6-b413-4696-918a-60ecb71eeba6	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1389	ESTRADIOL VAGINAL (ESTRADIOL) CREAM [BRYANT RANCH PREPACK]	104	Current NDC, 2 package rows	20241207_67f581cb-6d77-49fc-b2f3-976e3b57dcbf.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310169	estradiol 0.01 % Vaginal Cream	PSN	67f581cb-6d77-49fc-b2f3-976e3b57dcbf	105
310169	estradiol 0.1 MG/ML Vaginal Cream	SCD	67f581cb-6d77-49fc-b2f3-976e3b57dcbf	105
310169	estradiol 0.01 % Vaginal Cream	SY	67f581cb-6d77-49fc-b2f3-976e3b57dcbf	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1389-2	72162138902	1 TUBE in 1 CARTON (72162-1389-2) / 42.5 g in 1 TUBE	1 tube	2021-01-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESTRADIOL VAGINAL CREAM USP, 0.01%	Bryant Ranch Prepack	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	105