Home NDC 0378-0144 Tamoxifen Citrate
Product NDC 0378-0144
11-digit product format 003780144
Labeler code 0378
Product ID 0378-0144_2c1fe025-1eb2-4b2f-b8c9-5d0cfc3c683e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tamoxifen Citrate
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA074732
Marketing category ANDA
Marketing start 2003-02-20
Substance TAMOXIFEN CITRATE
Active strength 10 mg/1
Pharmacologic classes Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074732-001 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 A074732-002 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 82 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 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tamoxifen Citrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAMOXIFEN CITRATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7FRV7310N6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198240 Internal RxNorm lookup 313195 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 0378-0144-91 Tamoxifen Citrate 60 in 1 BOTTLE TABLET 60 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0144 TAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 1 package rows 20230823_7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0.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 0378-0144-91 00378014491 60 TABLET in 1 BOTTLE (0378-0144-91) 60 tablet 2004-02-20 0000-00-00 No No Current