Home NDC 0009-0271 Depo-Estradiol
Product NDC 0009-0271
11-digit product format 000090271
Labeler code 0009
Product ID 0009-0271_70957ffe-7710-4a3a-98fa-bf5d84f38ddb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol cypionate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Pharmacia & Upjohn Company LLC
Application ANDA085470
Marketing category ANDA
Marketing start 1979-08-15
Substance ESTRADIOL CYPIONATE
Active strength 5 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 A085470-001 DEPO-ESTRADIOL ESTRADIOL CYPIONATE 1MG/ML INJECTABLE / INJECTION Approved before 1982 A085470-002 DEPO-ESTRADIOL ESTRADIOL CYPIONATE 3MG/ML INJECTABLE / INJECTION Approved before 1982 A085470-003 DEPO-ESTRADIOL ESTRADIOL CYPIONATE 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982
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 4 · 123 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 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085470-002 DEPO-ESTRADIOL 3MG/ML INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085470-003 DEPO-ESTRADIOL 5MG/ML INJECTABLE / INJECTION RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A085470-001 DEPO-ESTRADIOL 1MG/ML INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base Depo-Estradiol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL CYPIONATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7E1DV054LO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 206417 Internal RxNorm lookup 310187 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 0009-0271-01 Depo-Estradiol 1 in 1 CARTON INJECTION 1 9 0009-0271-01 Depo-Estradiol 5 mL in 1 VIAL INJECTION 5 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-0271 DEPO-ESTRADIOL (ESTRADIOL CYPIONATE) INJECTION [PHARMACIA & UPJOHN COMPANY LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240229_9a4229fd-fecd-4ac1-9c4f-6d442533457f.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 0009-0271-01 00009027101 1 VIAL in 1 CARTON (0009-0271-01) / 5 mL in 1 VIAL 1 vial 1979-08-15 0000-00-00 No No Current