Home NDC 70700-274 Estradiol valerate
Product NDC 70700-274
11-digit product format 707000274
Labeler code 70700
Product ID 70700-274_390e2e08-4367-5639-e063-6294a90ac221
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol valerate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Xiromed, LLC
Application ANDA216656
Marketing category ANDA
Marketing start 2023-05-01
Substance ESTRADIOL VALERATE
Active strength 20 mg/mL
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216656-001 ESTRADIOL VALERATE ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 A216656-002 ESTRADIOL VALERATE ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 A216656-003 ESTRADIOL VALERATE ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO RS 2023-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216656-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2023-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216656-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2023-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216656-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2023-04-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Estradiol valerate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL VALERATE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OKG364O896 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310189 Internal RxNorm lookup 310190 Internal RxNorm lookup 310191 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70700-274-22 Estradiol valerate 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-274 ESTRADIOL VALERATE INJECTION [XIROMED, LLC] 7 Current NDC, 1 package rows 20240413_2e5c7559-7420-168d-6272-92bb4d20035d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70700-274-22 70700027422 5 mL in 1 VIAL, MULTI-DOSE (70700-274-22) 5 ml 2023-05-01 No No Current