FDA.reportPublic FDA data

Estradiol

Product NDC
69238-2448
11-digit product format
692382448
Labeler code
69238
Product ID
69238-2448_cebb61d3-34b7-44a7-aae7-d23e21651713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol Transdermal
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA216055
Marketing category
ANDA
Marketing start
2024-07-15
Substance
ESTRADIOL
Active strength
1.25 mg/1.25g
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
ESTRADIOL1.25 mg/1.25g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui2619677, 2619679, 2619681, 2619683, 2619685

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
69238-2448-1Estradiol1.25 g in 1 PACKETGEL1.2512
69238-2448-3Estradiol30 in 1 CARTONGEL3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2448-1GM - Gram69238-2448711e3da6-0018-48f6-8ad6-1566cbbd306e12024-09-09
69238-2448-3GM - Gram69238-244885703ebd-4b37-4644-9159-93d1848a4c5612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2448ESTRADIOL (ESTRADIOL TRANSDERMAL) GEL [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, 2 package rows20240715_9669a0e3-27e2-4f6c-961c-7a67e9f84cc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619677estradiol 0.1 % (0.25MG / 0.25GM) Transdermal GelPSN9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619679estradiol 0.1 % (0.5MG / 0.5GM) Transdermal GelPSN9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619681estradiol 0.1 % (0.75MG / 0.75GM) Transdermal GelPSN9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619685estradiol 0.1 % (1.25MG / 1.25GM) Transdermal GelPSN9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619683estradiol 0.1 % (1MG / 1GM) Transdermal GelPSN9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
26196831000 MG estradiol 0.001 MG/MG Topical GelSCD9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
26196851250 MG estradiol 0.001 MG/MG Topical GelSCD9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619677250 MG estradiol 0.001 MG/MG Topical GelSCD9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619679500 MG estradiol 0.001 MG/MG Topical GelSCD9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619681750 MG estradiol 0.001 MG/MG Topical GelSCD9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619677estradiol 0.1 % Transdermal Gel, 0.25 GMSY9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619679estradiol 0.1 % Transdermal Gel, 0.5 GMSY9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619681estradiol 0.1 % Transdermal Gel, 0.75 GMSY9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619683estradiol 0.1 % Transdermal Gel, 1 GMSY9669a0e3-27e2-4f6c-961c-7a67e9f84cc812
2619685estradiol 0.1 % Transdermal Gel, 1.25 GMSY9669a0e3-27e2-4f6c-961c-7a67e9f84cc812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2448-1692382448011.25 g in 1 PACKET1.25 gHistorical
69238-2448-36923824480330 PACKET in 1 CARTON (69238-2448-3) / 1.25 g in 1 PACKET (69238-2448-1) 30 packet2024-07-15NoNoHistorical