FDA.reportPublic FDA data

Estradiol

Product NDC
82868-038
Requested package NDC
82868-038-90
11-digit product format
828680038
Labeler code
82868
Product ID
82868-038_47f8d60a-201c-9809-e063-6394a90a63ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA217334
Marketing category
ANDA
Marketing start
2024-01-18
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217334-001ESTRADIOLESTRADIOL0.5MGTABLET / ORALAB2023-09-06
A217334-002ESTRADIOLESTRADIOL1MGTABLET / ORALAB2023-09-06
A217334-003ESTRADIOLESTRADIOL2MGTABLET / ORALAB2023-09-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217334-001AB
A217334-002AB
A217334-003AB

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 22:54:322026-06A217334-001ESTRADIOL0.5MGTABLET / ORALAB2023-09-06a50c72e98297…
2026-08-01 22:54:322026-06A217334-002ESTRADIOL1MGTABLET / ORALAB2023-09-06a50c72e98297…
2026-08-01 22:54:322026-06A217334-003ESTRADIOL2MGTABLET / ORALAB2023-09-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217334-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217334-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217334-003AB1a50c72e98297…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLRedpharm Drug5718f042-e8c0-b721-e063-6294a90a5bef2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLREMEDYREPACK INC.41f7a56c-4ce3-4cc6-803e-1ff662efef902026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLREMEDYREPACK INC.59a4b68d-a507-4809-a0c8-fd9799986d122026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLPreferred Pharmaceuticals, Inc.6d129a94-8ecd-40a3-9a95-c5e1ece41ab12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLDirect_Rx47e446f8-ac16-ea6b-e063-6394a90a17262026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLNorthwind Health Company, LLC106b92da-334c-542f-e063-6394a90aa65b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
ndc (package): 82868-038-90
ndc (product): 82868-038
ndc11 (package): 82868003890
EstradiolESTRADIOLNorthwind Health Company, LLC0a1e744c-7926-0e0c-e063-6294a90a80d02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLNorthStar Rx LLC1c2cd11a-e010-20b2-e063-6294a90a52d52025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLBryant Ranch Prepackff3bcb07-f6fe-4582-948a-21dbf1e55f552025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLCoupler LLC37c99e4d-fb0d-0e6e-e063-6394a90a69c82025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLPreferred Pharmaceuticals Inc.72fbd5a8-9c34-4790-84ed-79f5bd3ae0f02025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.aa396e57-0a93-49cc-82e5-cd35c987bb0b2025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLA-S Medication Solutionsf7e8dd35-c12f-46be-96f9-bf9a9b6f9a902024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLA-S Medication Solutions41f424ec-9d08-4fda-b21d-41e92da6e1f02024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.230c2eda-b0f1-d9ec-e063-6394a90a603c2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLBryant Ranch Prepack5e9bd73f-67db-44f9-a5ee-409eed765cd22024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLBryant Ranch Prepack9eb88585-4994-474f-bd63-c4e003bf6f202024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.1bbdb10b-9a32-3899-e063-6294a90ab26d2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3fe899db-a8cd-4a31-88fb-1129be96b4d92024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217334
application number: ANDA217334

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 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
197658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
106b92da-334c-542f-e063-6394a90aa65bAvailable 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
82868-038-30Estradiol30 in 1 BOTTLE, PLASTICTABLET302
82868-038-90Estradiol90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-038ESTRADIOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20240220_106b92da-334c-542f-e063-6394a90aa65b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197658estradiol 1 MG Oral TabletPSN106b92da-334c-542f-e063-6394a90aa65b2
197658estradiol 1 MG Oral TabletSCD106b92da-334c-542f-e063-6394a90aa65b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-038-908286800389090 TABLET in 1 BOTTLE, PLASTIC (82868-038-90) 90 tablet2024-01-18NoNoCurrent