FDA.reportPublic FDA data

Estradiol Vaginal

Product NDC
72162-1389
Requested package NDC
72162-1389-2
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210194-001ESTRADIOLESTRADIOL0.01%CREAM / VAGINALAB2018-01-22

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210194-001ESTRADIOL0.01%CREAM / VAGINALAB2018-01-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210194-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estradiol VaginalESTRADIOLRedpharm Drug546c168d-2a85-69b6-e063-6294a90a22ac2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210194
application number: ANDA210194
Estradiol VaginalESTRADIOLA-S Medication Solutions0137d491-6917-4060-9b32-e0cd7b0badbb2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210194
application number: ANDA210194
Estradiol VaginalESTRADIOLBryant Ranch Prepack67f581cb-6d77-49fc-b2f3-976e3b57dcbf2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210194
application number: ANDA210194
ndc (package): 72162-1389-2
ndc (product): 72162-1389
ndc11 (package): 72162138902
Estradiol VaginalESTRADIOLAvKAREbb7b442d-b8c3-b7f0-e053-2a95a90a2c942026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210194
application number: ANDA210194
Estradiol VaginalESTRADIOLPadagis Israel Pharmaceuticals Ltdf76232ed-b109-43d1-bf2e-d41b6420c37d2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210194
application number: ANDA210194
Estradiol VaginalESTRADIOLBryant Ranch Prepackf3806b5d-ebd6-43b4-adfa-a1fe86d806422025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210194
application number: ANDA210194
Estradiol VaginalESTRADIOLNuCare Pharmaceuticals, Inc.2e5a4d78-6683-4fb8-e063-6294a90a49e72025-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210194
application number: ANDA210194
Estradiol VaginalESTRADIOLBryant Ranch Prepacke7b15ec3-e195-44a6-bdd7-9b6de2b235b82024-07-26Boxed warning, Warnings, Adverse reactionsExact 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
IngredientStrength
ESTRADIOL.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4TI98Z838EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310169Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
67f581cb-6d77-49fc-b2f3-976e3b57dcbfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1389-2Estradiol Vaginal1 in 1 CARTONCREAM1105
72162-1389-2Estradiol Vaginal42.5 g in 1 TUBECREAM42.5105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1389-2GM - Gram72162-1389e23043d6-b413-4696-918a-60ecb71eeba612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1389ESTRADIOL VAGINAL (ESTRADIOL) CREAM [BRYANT RANCH PREPACK]104Current NDC, 2 package rows20241207_67f581cb-6d77-49fc-b2f3-976e3b57dcbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310169estradiol 0.01 % Vaginal CreamPSN67f581cb-6d77-49fc-b2f3-976e3b57dcbf105
310169estradiol 0.1 MG/ML Vaginal CreamSCD67f581cb-6d77-49fc-b2f3-976e3b57dcbf105
310169estradiol 0.01 % Vaginal CreamSY67f581cb-6d77-49fc-b2f3-976e3b57dcbf105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1389-2721621389021 TUBE in 1 CARTON (72162-1389-2) / 42.5 g in 1 TUBE1 tube2021-01-06NoNoCurrent