Home Applications 074655 Application 074655
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE No No 002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE No Yes
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 A074655-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 A074655-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22
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 · 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 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-1354 Ranitidine Hydrochloride Ranitidine Hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0781-2855 Ranitidine Hydrochloride Ranitidine Hydrochloride Sandoz Inc ANDA Current 0781-2855 Ranitidine Hydrochloride Ranitidine Hydrochloride Sandoz Inc ANDA Current 0781-2855 Ranitidine Hydrochloride Ranitidine Hydrochloride Sandoz Inc ANDA Current 0781-2865 Ranitidine Hydrochloride Ranitidine Hydrochloride Sandoz Inc ANDA Current 0781-2865 Ranitidine Hydrochloride Ranitidine Hydrochloride Sandoz Inc ANDA Current 0781-2865 Ranitidine Hydrochloride Ranitidine Hydrochloride Sandoz Inc ANDA Current 21695-337 Ranitidine Hydrochloride Ranitidine Hydrochloride Rebel Distributors Corp ANDA Current 21695-338 Ranitidine Hydrochloride Ranitidine Hydrochloride Rebel Distributors Corp ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22349 ORIG 1997-10-22