FDA.reportPublic FDA data

Estradiol

Product NDC
0555-0886
11-digit product format
005550886
Labeler code
0555
Product ID
0555-0886_e9b2e697-6e57-436a-933d-5554ca402da7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040197
Marketing category
ANDA
Marketing start
1997-10-28
Substance
ESTRADIOL
Active strength
1 mg/1
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui197657, 197658, 197659

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
0555-0886-02Estradiol100 in 1 BOTTLETABLET10016
0555-0886-04Estradiol500 in 1 BOTTLETABLET50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0886-02EA - Each0555-08869053a198-2be3-4d27-b22e-739e243a5a0112013-02-13
0555-0886-04EA - Each0555-0886f24357ae-856e-42cf-b97b-d3223b0c490e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [BARR LABORATORIES INC.]4
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [BARR LABORATORIES INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ESTRADIOL TABLET [BARR LABORATORIES INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JESTRADIOL TABLET [BARR LABORATORIES INC.]4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KESTRADIOL TABLET [BARR LABORATORIES INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRADIOL TABLET [BARR LABORATORIES INC.]4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MESTRADIOL TABLET [BARR LABORATORIES INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTRADIOL TABLET [BARR LABORATORIES INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL TABLET [BARR LABORATORIES INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESTRADIOL TABLET [BARR LABORATORIES INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ESTRADIOL TABLET [BARR LABORATORIES INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESTRADIOL TABLET [BARR LABORATORIES INC.]4
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
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
0555-0886ESTRADIOL TABLET [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20240308_c4936878-1643-4e7f-9b0d-e4957935aef2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197657estradiol 0.5 MG Oral TabletPSN3e84e3e7-4b50-407f-a215-45363b54138431
197658estradiol 1 MG Oral TabletPSN3e84e3e7-4b50-407f-a215-45363b54138431
197659estradiol 2 MG Oral TabletPSN3e84e3e7-4b50-407f-a215-45363b54138431
197657estradiol 0.5 MG Oral TabletSCD3e84e3e7-4b50-407f-a215-45363b54138431
197658estradiol 1 MG Oral TabletSCD3e84e3e7-4b50-407f-a215-45363b54138431
197659estradiol 2 MG Oral TabletSCD3e84e3e7-4b50-407f-a215-45363b54138431
197657estradiol 0.5 MG Oral TabletPSN80d6644a-d6f2-48e7-a685-92c4255b19fe17
197658estradiol 1 MG Oral TabletPSN80d6644a-d6f2-48e7-a685-92c4255b19fe17
197659estradiol 2 MG Oral TabletPSN80d6644a-d6f2-48e7-a685-92c4255b19fe17
197657estradiol 0.5 MG Oral TabletSCD80d6644a-d6f2-48e7-a685-92c4255b19fe17
197658estradiol 1 MG Oral TabletSCD80d6644a-d6f2-48e7-a685-92c4255b19fe17
197659estradiol 2 MG Oral TabletSCD80d6644a-d6f2-48e7-a685-92c4255b19fe17
197657estradiol 0.5 MG Oral TabletPSNc4936878-1643-4e7f-9b0d-e4957935aef216
197658estradiol 1 MG Oral TabletPSNc4936878-1643-4e7f-9b0d-e4957935aef216
197659estradiol 2 MG Oral TabletPSNc4936878-1643-4e7f-9b0d-e4957935aef216
197657estradiol 0.5 MG Oral TabletSCDc4936878-1643-4e7f-9b0d-e4957935aef216
197658estradiol 1 MG Oral TabletSCDc4936878-1643-4e7f-9b0d-e4957935aef216
197659estradiol 2 MG Oral TabletSCDc4936878-1643-4e7f-9b0d-e4957935aef216
197658estradiol 1 MG Oral TabletPSNf3a77482-f490-f350-e053-2a95a90ad8cb8
197658estradiol 1 MG Oral TabletSCDf3a77482-f490-f350-e053-2a95a90ad8cb8
197658estradiol 1 MG Oral TabletPSN7e570b07-2a9e-49bf-b224-1e34f6eda3ab6
197658estradiol 1 MG Oral TabletSCD7e570b07-2a9e-49bf-b224-1e34f6eda3ab6
197658estradiol 1 MG Oral TabletPSNf6cb38ab-fdff-9c07-e053-6294a90ad59a4
197658estradiol 1 MG Oral TabletSCDf6cb38ab-fdff-9c07-e053-6294a90ad59a4
197658estradiol 1 MG Oral TabletPSN7f3c96ce-c855-4372-95ba-7759dd82bcca3
197658estradiol 1 MG Oral TabletPSN20b50139-4e13-4f0c-aaf5-ecb83911d9e63
197658estradiol 1 MG Oral TabletSCD7f3c96ce-c855-4372-95ba-7759dd82bcca3
197658estradiol 1 MG Oral TabletSCD20b50139-4e13-4f0c-aaf5-ecb83911d9e63
197657estradiol 0.5 MG Oral TabletPSN37f3094c-f02d-4a9c-8e30-2c4752bc62ed2
197658estradiol 1 MG Oral TabletPSN8735213f-9d8d-6300-e053-2991aa0afb812
197658estradiol 1 MG Oral TabletPSN265a1ee1-f314-4324-a2e1-0120a9a00a202
197658estradiol 1 MG Oral TabletPSNc8ac2e13-58d5-4e70-e053-2995a90aff042
197658estradiol 1 MG Oral TabletPSN37f3094c-f02d-4a9c-8e30-2c4752bc62ed2
197659estradiol 2 MG Oral TabletPSN37f3094c-f02d-4a9c-8e30-2c4752bc62ed2
197657estradiol 0.5 MG Oral TabletSCD37f3094c-f02d-4a9c-8e30-2c4752bc62ed2
197658estradiol 1 MG Oral TabletSCD37f3094c-f02d-4a9c-8e30-2c4752bc62ed2
197658estradiol 1 MG Oral TabletSCDc8ac2e13-58d5-4e70-e053-2995a90aff042
197658estradiol 1 MG Oral TabletSCD265a1ee1-f314-4324-a2e1-0120a9a00a202
197658estradiol 1 MG Oral TabletSCD8735213f-9d8d-6300-e053-2991aa0afb812
197659estradiol 2 MG Oral TabletSCD37f3094c-f02d-4a9c-8e30-2c4752bc62ed2
197658estradiol 1 MG Oral TabletPSN7712c639-36c5-4c0f-aa74-fd41615407611
197658estradiol 1 MG Oral TabletPSN8febb45d-a1fc-702c-e053-2995a90a3e621
197658estradiol 1 MG Oral TabletPSNd1f09c5c-8f31-0911-e053-2a95a90af1b81
197659estradiol 2 MG Oral TabletPSN7712c639-36c5-4c0f-aa74-fd41615407611
197658estradiol 1 MG Oral TabletSCD8febb45d-a1fc-702c-e053-2995a90a3e621
197658estradiol 1 MG Oral TabletSCDd1f09c5c-8f31-0911-e053-2a95a90af1b81
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0886-0200555088602100 TABLET in 1 BOTTLE (0555-0886-02) 100 tablet1997-10-280000-00-00NoNoCurrent
0555-0886-0400555088604500 TABLET in 1 BOTTLE (0555-0886-04) 500 tablet1997-10-280000-00-00NoNoCurrent