Home NDC 0143-9289 Estradiol Valerate
Product NDC 0143-9289
11-digit product format 001439289
Labeler code 0143
Product ID 0143-9289_5fa9d3b5-6bfd-40e9-900e-21427f6c4d21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Estradiol Valerate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA203723
Marketing category ANDA
Marketing start 2020-04-21
Substance ESTRADIOL VALERATE
Active strength 10 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 A203723-001 ESTRADIOL VALERATE ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 A203723-002 ESTRADIOL VALERATE ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 A203723-003 ESTRADIOL VALERATE ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21
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 3 · 111 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 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203723-002 ESTRADIOL VALERATE 20MG/ML INJECTABLE / INJECTION AO 2020-04-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203723-003 ESTRADIOL VALERATE 40MG/ML INJECTABLE / INJECTION AO 2020-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203723-001 ESTRADIOL VALERATE 10MG/ML INJECTABLE / INJECTION AO 2020-04-21 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Estradiol Valerate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL VALERATE 10 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 0143-9289-01 Estradiol Valerate 1 in 1 CARTON INJECTION 1 7 0143-9289-01 Estradiol Valerate 5 mL in 1 VIAL INJECTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9289 ESTRADIOL VALERATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240629_66f40ab0-4432-4e85-b709-a0bc076868c6.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 Marketing end Sample Exclude flag Status 0143-9289-01 00143928901 1 VIAL in 1 CARTON (0143-9289-01) / 5 mL in 1 VIAL 1 vial 2020-04-21 0000-00-00 No No Current