Home Applications 020520 Application 020520
Type NDA
Sponsor SANOFI US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZANTAC 75 RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 75MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020520-001 ZANTAC 75 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL RLD 1995-12-19
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 · 42 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 2026-08-18 06:07:40 2026-07 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020520-001 ZANTAC 75 EQ 75MG BASE TABLET / ORAL RLD 1995-12-19 e64feba35796…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0122 Zantac 75 ranitidine Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 0597-0122 Zantac 75 ranitidine Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 41167-0300 Zantac 75 Ranitidine Hydrochloride Chattem, Inc. NDA Current 41167-0300 Zantac 75 Ranitidine Hydrochloride Chattem, Inc. NDA Current 50269-222 Zantac 75 RANITIDINE JC World Bell Wholesale Co., Inc. NDA Current 50269-222 Zantac 75 RANITIDINE JC World Bell Wholesale Co., Inc. NDA Current 67751-152 Zantac 75 RANITIDINE Navajo Manufacturing Company Inc. NDA Current 67751-152 Zantac 75 RANITIDINE Navajo Manufacturing Company Inc. NDA Current 68151-2584 Zantac 75 ranitidine Carilion Materials Management NDA Current 76413-317 Zantac ranitidine Central Texas Community Health Centers NDA Current