Home NDC 0597-0120 Zantac Maximum Strength 150 Cool Mint
Product NDC 0597-0120
11-digit product format 005970120
Labeler code 0597
Product ID 0597-0120_97cb5218-4c7e-5ae5-e053-2995a90af3f2
Type HUMAN OTC DRUG
Nonproprietary name ranitidine
Dosage form TABLET, COATED
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals Inc.
Application NDA021698
Marketing category NDA
Marketing start 2006-12-21
Marketing end 2021-11-30
Substance RANITIDINE HYDROCHLORIDE
Active strength 150 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 3 · 156 matching rows.
View current auxiliary records. · View the auxiliary file history.
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ranitidine hydrochloride ACTIVE INGREDIENT BK76465IHM ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 ranitidine ACTIVE MOIETY 884KT10YB7 ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZANTAC MAXIMUM STRENGTH 150 COOL MINT (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0120-06 00597012006 1 BLISTER PACK in 1 CARTON (0597-0120-06) > 3 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2006-12-21 2021-11-30 No No Current 0597-0120-08 00597012008 1 TABLET, COATED in 1 POUCH (0597-0120-08) 2006-12-21 2021-11-30 No No Current 0597-0120-09 00597012009 4 BLISTER PACK in 1 CARTON (0597-0120-09) > 8 TABLET, COATED in 1 BLISTER PACK 4 blister pack 2006-12-21 2021-11-30 No No Current 0597-0120-24 00597012024 3 BLISTER PACK in 1 CARTON (0597-0120-24) > 8 TABLET, COATED in 1 BLISTER PACK 3 blister pack 2006-12-21 2021-11-30 No No Current 0597-0120-38 00597012038 1 BLISTER PACK in 1 CARTON (0597-0120-38) > 8 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2006-12-21 2021-11-30 No No Current 0597-0120-50 00597012050 1 BOTTLE in 1 CARTON (0597-0120-50) > 50 TABLET, COATED in 1 BOTTLE 1 bottle 2006-12-21 2021-11-30 No No Current 0597-0120-68 00597012068 1 BOTTLE in 1 CARTON (0597-0120-68) > 65 TABLET, COATED in 1 BOTTLE 1 bottle 2006-12-21 2021-11-30 No No Current 0597-0120-76 00597012076 2 BLISTER PACK in 1 CARTON (0597-0120-76) > 8 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2006-12-21 2021-11-30 No No Current 0597-0120-78 00597012078 1 BOTTLE in 1 CARTON (0597-0120-78) > 78 TABLET, COATED in 1 BOTTLE 1 bottle 2006-12-21 2021-11-30 No No Current 0597-0120-80 00597012080 80 POUCH in 1 CARTON (0597-0120-80) > 1 TABLET, COATED in 1 POUCH 80 pouch 2006-12-21 2021-11-30 No No Current 0597-0120-82 00597012082 80 POUCH in 1 CARTON (0597-0120-82) > 1 TABLET, COATED in 1 POUCH 80 pouch 2006-12-21 2021-11-30 No No Current 0597-0120-87 00597012087 1 BOTTLE in 1 CARTON (0597-0120-87) > 85 TABLET, COATED in 1 BOTTLE 1 bottle 2006-12-21 2021-11-30 No No Current