Home Applications 021698 Application 021698
Type NDA
Sponsor SANOFI US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZANTAC 150 RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Yes Yes 002 ZANTAC 150 RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021698-001 ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 N021698-002 ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL RLD 2007-03-13
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 · 84 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 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD, RS 2004-08-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021698-001 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2004-08-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021698-002 ZANTAC 150 EQ 150MG BASE TABLET / ORAL RLD 2007-03-13 bb7c543d1eb4…
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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0120 Zantac Maximum Strength 150 Cool Mint ranitidine Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 0597-0120 Zantac Maximum Strength 150 Cool Mint ranitidine Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 0597-0121 Maximum Strength Zantac ranitidine Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 0597-0121 Maximum Strength Zantac ranitidine Boehringer Ingelheim Pharmaceuticals Inc. NDA Current 41167-0310 Zantac 150 Ranitidine Hydrochloride Chattem, Inc. NDA Current 41167-0310 Zantac 150 Ranitidine Hydrochloride Chattem, Inc. NDA Current 41167-0320 Zantac 150 Ranitidine Hydrochloride Chattem, Inc. NDA Current 41167-0320 Zantac 150 Ranitidine Hydrochloride Chattem, Inc. NDA Current 50269-220 Zantac 150 RANITIDINE JC World Bell Wholesale Co., Inc. NDA Current 50269-220 Zantac 150 RANITIDINE JC World Bell Wholesale Co., Inc. NDA Current 66715-9736 Zantac 150 Ranitidine Lil' Drug Store Products, Inc NDA Current 66715-9736 Zantac 150 Ranitidine Lil' Drug Store Products, Inc NDA Current 66715-9736 Zantac 150 Ranitidine Lil' Drug Store Products, Inc NDA Current 67751-151 Zantac 150 RANITIDINE Navajo Manufacturing Company Inc. NDA Current 67751-151 Zantac 150 RANITIDINE Navajo Manufacturing Company Inc. NDA Current