ELESTRIN

Product NDC: 0037-4801
11-digit product format: 000374801
Labeler code: 0037
Product ID: 0037-4801_1246f55c-8c45-4fbd-af2c-91bb74e8310b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESTRADIOL
Dosage form: GEL, METERED
Route: TOPICAL
Labeler: Viatris Specialty LLC
Application: NDA021813
Marketing category: NDA
Marketing start: 2014-06-02
Substance: ESTRADIOL
Active strength: .52 mg/.87g
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
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
N021813-001	ELESTRIN	ESTRADIOL	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2006-12-15

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.

Product history page 1 of 2 · 41 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	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021813-001	7198801	2022-06-25	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021813-001	7198801	2022-06-25	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021813-001	7198801	2022-06-25	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021813-001	7470433	2021-08-03	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021813-001	7198801	2022-06-25	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021813-001	7198801	2022-06-25	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021813-001	7470433	2021-08-03	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021813-001	7198801	2022-06-25	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021813-001	7470433	2021-08-03	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021813-001	7198801	2022-06-25	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021813-001	7470433	2021-08-03	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021813-001	7198801	2022-06-25	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021813-001	7470433	2021-08-03	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021813-001	7198801	2022-06-25	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021813-001	7470433	2021-08-03	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021813-001	7198801	2022-06-25	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021813-001	7470433	2021-08-03	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021813-001	7198801	2022-06-25	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021813-001	7470433	2021-08-03	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021813-001	7198801	2022-06-25	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021813-001	7470433	2021-08-03	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021813-001	7198801	2022-06-25	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021813-001	7198801	2022-06-25	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021813-001	7198801	2022-06-25	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021813-001	7198801	2022-06-25	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021813-001	7198801	2022-06-25	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021813-001	7198801	2022-06-25	Drug product	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.52 mg/.87g

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
226597	Internal RxNorm lookup
706467	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
eff2dea1-f117-11e3-ac10-0800200c9a66	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
0037-4801-35	ELESTRIN	35 g in 1 BOTTLE, PUMP	GEL, METERED	35		18
0037-4801-70	ELESTRIN	2 in 1 CARTON	GEL, METERED	2		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-4801-35	GM - Gram	0037-4801	e7fc574a-b35b-4c4e-b454-6717e19c7dd5	1	2015-03-03
0037-4801-70	GM - Gram	0037-4801	e8ea825a-7eef-4c59-b6b0-060ae639d86b	1	2018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ELESTRIN (ESTRADIOL GEL 0.06%) GEL, METERED [MEDA PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0037-4801	ELESTRIN (ESTRADIOL) GEL, METERED [MEDA PHARMACEUTICALS INC.]	17	Current NDC, Legacy NDC, 2 package rows	20240608_eff2dea1-f117-11e3-ac10-0800200c9a66.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
ELESTRIN	ESTRADIOL	Viatris Specialty LLC	eff2dea1-f117-11e3-ac10-0800200c9a66	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021813 application number: NDA021813 ndc (product): 0037-4801

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
706467	ELESTRIN 0.06 % Topical Gel	PSN	eff2dea1-f117-11e3-ac10-0800200c9a66	18
226597	estradiol 0.06 % Topical Gel	PSN	eff2dea1-f117-11e3-ac10-0800200c9a66	18
706467	estradiol 0.0006 MG/MG Topical Gel [Elestrin]	SBD	eff2dea1-f117-11e3-ac10-0800200c9a66	18
226597	estradiol 0.0006 MG/MG Topical Gel	SCD	eff2dea1-f117-11e3-ac10-0800200c9a66	18
706467	Elestrin 0.0006 MG/MG Topical Gel	SY	eff2dea1-f117-11e3-ac10-0800200c9a66	18
706467	Elestrin 0.06 % Topical Gel	SY	eff2dea1-f117-11e3-ac10-0800200c9a66	18
226597	estradiol 0.06 % Topical Gel	SY	eff2dea1-f117-11e3-ac10-0800200c9a66	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-4801-35	00037480135	35 g in 1 BOTTLE, PUMP	35 g					Historical
0037-4801-70	00037480170	2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)		2018-11-05	0000-00-00	No	No	Current