Estradiol

Product NDC
33261-667
11-digit product format
332610667
Labeler code
33261
Product ID
33261-667_81b5ab1e-b277-43ac-9a7b-d14d60457c12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040197
Marketing category
ANDA
Marketing start
1997-10-28
Marketing end
0000-00-00
Substance
ESTRADIOL
Active strength
1 mg/1
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-667-302020-01-31C16284748780-19d75b9d0-cd39-f424-e053-dadaa90a57ceESTRADIOL TABLETS, USP
33261-667-602020-01-31C16284748780-19d75b9d0-cd39-f424-e053-dadaa90a57ceESTRADIOL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-667-30Estradiol30 in 1 BOTTLE, PLASTICTABLET301
33261-667-60Estradiol60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-667-30EA - Each33261-667493e48d6-f873-4755-9b13-33953b2ed7a212015-10-02
33261-667-60EA - Each33261-667d1f93cac-f0eb-400f-ba54-bf711e4e3a8312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-667ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140107_7712c639-36c5-4c0f-aa74-fd4161540761.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197658estradiol 1 MG Oral TabletPSN7712c639-36c5-4c0f-aa74-fd41615407611
197659estradiol 2 MG Oral TabletPSN7712c639-36c5-4c0f-aa74-fd41615407611
197658estradiol 1 MG Oral TabletSCD7712c639-36c5-4c0f-aa74-fd41615407611
197659estradiol 2 MG Oral TabletSCD7712c639-36c5-4c0f-aa74-fd41615407611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-667-303326106673030 in 1 BOTTLE, PLASTICHistorical
33261-667-603326106676060 in 1 BOTTLE, PLASTICHistorical