Home NDC 71335-0893-5 Tamoxifen Citrate
Product NDC 71335-0893
Requested package NDC 71335-0893-5
11-digit product format 713350893
Labeler code 71335
Product ID 71335-0893_a4a8d2bc-8324-47a3-985b-114448547c7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tamoxifen Citrate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA074732
Marketing category ANDA
Marketing start 2003-02-20
Marketing end 0000-00-00
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 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-0893-5 71335089305 58 TABLET in 1 BOTTLE (71335-0893-5) 58 tablet 2018-07-06 0000-00-00 No No Current