Home NDC 42291-724-18 Ranitidine
Product NDC 42291-724
Requested package NDC 42291-724-18
11-digit product format 422910724
Labeler code 42291
Product ID 42291-724_ba4d704e-a080-6b0b-e053-2a95a90a6bc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA077824
Marketing category ANDA
Marketing start 2014-08-18
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 2022-12-31
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 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [AVKARE, INC.] 3 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [AVKARE, INC.] 3 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U RANITIDINE TABLET [AVKARE, INC.] 3 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 RANITIDINE TABLET [AVKARE, INC.] 3 D&c Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G RANITIDINE TABLET [AVKARE, INC.] 3 Fd&c Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 RANITIDINE TABLET [AVKARE, INC.] 3 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE TABLET [AVKARE, INC.] 3 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 RANITIDINE TABLET [AVKARE, INC.] 3 Polydextrose INACTIVE INGREDIENT VH2XOU12IE RANITIDINE TABLET [AVKARE, INC.] 3 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE TABLET [AVKARE, INC.] 3 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE TABLET [AVKARE, INC.] 3 Triethyl Citrate INACTIVE INGREDIENT 8Z96QXD6UM RANITIDINE TABLET [AVKARE, INC.] 3
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 Units Marketing start Marketing end Sample Exclude flag Status 42291-724-18 42291072418 180 TABLET in 1 BOTTLE (42291-724-18) 180 tablet 2014-08-18 0000-00-00 No No Current