Home NDC 75907-059 Tamoxifen Citrate
Product NDC 75907-059
11-digit product format 759070059
Labeler code 75907
Product ID 75907-059_f632608a-0743-4a7e-33a8-2ae28eccfcb9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tamoxifen Citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Labratories Inc.
Application ANDA075797
Marketing category ANDA
Marketing start 2024-08-22
Substance TAMOXIFEN CITRATE
Active strength 20 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 A075797-001 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 A075797-002 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 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 2 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 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 cb3db0bc1861…
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 20 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 75907-059-10 Tamoxifen Citrate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1 75907-059-30 Tamoxifen Citrate 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-059 TAMOXIFEN CITRATE TABLET, FILM COATED [DR. REDDY'S LABRATORIES INC.] 1 Current NDC, 2 package rows 20240823_c6c6a643-57d6-7ea5-7da0-e8a66802468a.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 75907-059-10 75907005910 1000 TABLET, FILM COATED in 1 BOTTLE (75907-059-10) 2024-08-22 No No Current 75907-059-30 75907005930 30 TABLET, FILM COATED in 1 BOTTLE (75907-059-30) 2024-08-22 No No Current