Home NDC 71610-362-80 Ranitidine
Product NDC 71610-362
Requested package NDC 71610-362-80
11-digit product format 716100362
Labeler code 71610
Product ID 71610-362_b9f9db96-e998-49f8-b108-8b9e06048a14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, 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 2020-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 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 · 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 A077824-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2006-10-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077824-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 2006-10-13 84e616aacf4f…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…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-362-53 Ranitidine 60 in 1 BOTTLE TABLET 60 1 71610-362-80 Ranitidine 180 in 1 BOTTLE TABLET 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-362 RANITIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 2 package rows 20191206_dc729434-8340-40e3-9e5c-973c01460196.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 Units Marketing start Marketing end Sample Exclude flag Status 71610-362-80 71610036280 180 TABLET in 1 BOTTLE (71610-362-80) 180 tablet 2019-11-13 0000-00-00 No No Current