Home NDC 49999-428-30 Ranitidine
Product NDC 49999-428
Requested package NDC 49999-428-30
11-digit product format 499990428
Labeler code 49999
Product ID 49999-428_fa668f2f-5939-495b-bb42-eb2ff4d255b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA078542
Marketing category ANDA
Marketing start 2008-11-19
Marketing end 0000-00-00
Substance RANITIDINE HYDROCHLORIDE
Active strength 300 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A078542-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2008-11-19 A078542-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2008-11-19
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 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2008-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2008-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2008-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2008-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2008-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2008-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078542-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2008-11-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078542-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 2008-11-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49999-428-30 49999042830 30 TABLET, FILM COATED in 1 BOTTLE (49999-428-30) 2008-11-19 0000-00-00 No No Current