Home NDC 33261-099 Ranitidine
Product NDC 33261-099
11-digit product format 332610099
Labeler code 33261
Product ID 33261-099_99a8f78f-d074-4c2a-8dff-b0637b2a2324
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form TABLET
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA077824
Marketing category ANDA
Marketing start 2009-12-16
Marketing end 0000-00-00
Substance RANITIDINE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 5 · 252 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-20 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-60 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-20 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-99 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-90 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-099-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-20 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-60 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-20 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-99 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-90 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-099-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-20 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-60 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-20 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-99 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-90 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-099-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-20 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-60 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-20 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-99 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-90 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-099-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…
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 A077824-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 A077824-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13
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 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 2006-10-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB RS 2006-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-099 RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC] 7 Legacy NDC, 7 package rows 20171117_9add19e6-f71c-4950-ae63-90e152a9cfe0.zip
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-099-02 33261009902 120 in 1 BOTTLE Historical 33261-099-10 33261009910 10 in 1 BOTTLE Historical 33261-099-20 33261009920 20 in 1 BOTTLE Historical 33261-099-30 33261009930 30 in 1 BOTTLE Historical 33261-099-60 33261009960 60 in 1 BOTTLE Historical 33261-099-90 33261009990 90 in 1 BOTTLE Historical 33261-099-99 33261009999 180 in 1 BOTTLE Historical