Home NDC 63739-269 Tamoxifen Citrate
Product NDC 63739-269
11-digit product format 637390269
Labeler code 63739
Product ID 63739-269_b944fc3d-fdde-af43-e053-2a95a90a2ea8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tamoxifen Citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler McKesson Corporation dba SKY Packaging
Application ANDA075797
Marketing category ANDA
Marketing start 2003-02-20
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63739-269-42 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63739-269-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63739-269-42 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63739-269-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63739-269-42 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63739-269-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63739-269-42 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63739-269-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63739-269-42 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63739-269-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63739-269-42 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63739-269-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63739-269-42 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63739-269-10 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63739-269-42 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63739-269-10 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63739-269-42 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63739-269-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63739-269-42 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63739-269-10 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63739-269-42 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63739-269-10 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63739-269-42 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63739-269-10 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 63739-269-10 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63739-269-10 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63739-269-10 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 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 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075797-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075797-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB RS 2003-02-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63739-269-10 Tamoxifen Citrate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 11 63739-269-10 Tamoxifen Citrate 10 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 10 11 63739-269-42 Tamoxifen Citrate 60 in 1 BOTTLE TABLET, FILM COATED 60 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63739-269 TAMOXIFEN CITRATE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING] 11 Legacy NDC, 3 package rows 20210120_151ce76c-2d44-4c82-850d-ab213bea4d6b.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 Units Marketing start Marketing end Sample Exclude flag Status 63739-269-10 63739026910 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-269-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2003-02-20 0000-00-00 No No Current 63739-269-42 63739026942 60 in 1 BOTTLE Historical