Home Applications 075180 Application 075180
Type ANDA
Sponsor PAR PHARM 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 43 .
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 A075180-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 A075180-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28
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 · 86 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 2026-09-14 22:38:34 2026-08 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1999-01-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1999-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1999-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1999-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1999-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1999-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1999-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1999-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075180-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1999-01-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075180-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1999-01-28 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 50 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 49884-545 Ranitidine ranitidine Par Pharmaceutical Inc ANDA Current 49999-043 Ranitidine Ranitidine Lake Erie Medical DBA Qua ANDA Current 53808-0774 Ranitidine Ranitidine State of Florida DOH Central Pharmacy ANDA Current 63739-266 Ranitidine ranitidine McKesson Corporation dba SKY Packaging ANDA Current 63739-266 Ranitidine ranitidine McKesson Corporation ANDA Current 67046-650 Ranitidine Ranitidine Contract Pharmacy Services-PA ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30785 ORIG 1999-01-28