Home Applications 075165 Application 075165
Type ANDA
Sponsor HERITAGE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE No No 002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE No 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 A075165-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 A075165-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30
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 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1998-09-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1998-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075165-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-09-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075165-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-09-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0172-4357 Ranitidine Ranitidine Teva Pharmaceuticals USA, Inc. ANDA Current 0172-4358 Ranitidine Ranitidine Teva Pharmaceuticals USA, Inc. ANDA Current 0615-4513 Ranitidine Ranitidine NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-4514 Ranitidine Ranitidine NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 55289-505 Ranitidine Ranitidine PD-Rx Pharmaceuticals, Inc. ANDA Current 66116-518 Ranitidine Ranitidine MedVantx, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8546 ORIG 1998-09-30