Home NDC 70771-1185-9 Tamoxifen Citrate
Product NDC 70771-1185
Requested package NDC 70771-1185-9
11-digit product format 707711185
Labeler code 70771
Product ID 70771-1185_780b2275-d2c9-4018-890c-aeff05b32845
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tamoxifen Citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA206694
Marketing category ANDA
Marketing start 2018-01-03
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 2023-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70771-1185 70771-1185-9 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70771-1185 70771-1185-9 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A206694-001 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 A206694-002 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27
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 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206694-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2017-10-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206694-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2017-10-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1185 TAMOXIFEN CITRATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20231005_70052366-80f3-41bc-b2dd-c1efe9317243.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70771-1185-9 70771118509 90 TABLET, FILM COATED in 1 BOTTLE (70771-1185-9) 2018-01-03 0000-00-00 No No Current