Home NDC 68071-3990 Tamoxifen Citrate
Product NDC 68071-3990
11-digit product format 680713990
Labeler code 68071
Product ID 68071-3990_50b2fd97-c6bd-843b-e063-6294a90ac6fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tamoxifen Citrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA213358
Marketing category ANDA
Marketing start 2020-08-14
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 2027-12-31
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 A213358-001 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 A213358-002 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14
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 2 · 74 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 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213358-001 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2020-08-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213358-002 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2020-08-14 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tamoxifen Citrate
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198240 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 68071-3990-3 Tamoxifen Citrate 30 in 1 BOTTLE TABLET, FILM COATED 30 2
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tamoxifen Citrate TAMOXIFEN CITRATE NuCare Pharmaceuticals, Inc. 509f8ba3-214d-aec8-e063-6294a90af498 2026-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213358 application number: ANDA213358 ndc (product): 68071-3990 Tamoxifen Citrate TAMOXIFEN CITRATE Bryant Ranch Prepack 9b4a8abc-6e56-40c5-a826-1d1f3c0786e1 2024-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213358 application number: ANDA213358 Tamoxifen Citrate TAMOXIFEN CITRATE Bryant Ranch Prepack feb96056-79f5-4024-ab0e-fdbb8d4ab862 2024-01-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213358 application number: ANDA213358 Tamoxifen Citrate TAMOXIFEN CITRATE Aurobindo Pharma Limited a596c715-8e30-43c1-aba3-4fe5de6729fa 2020-08-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213358 application number: ANDA213358
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68071-3990-3 68071399003 30 TABLET, FILM COATED in 1 BOTTLE (68071-3990-3) 2026-04-29 No No Current