Home NDC 0615-1354 Ranitidine Hydrochloride
Product NDC 0615-1354
11-digit product format 006151354
Labeler code 0615
Product ID 0615-1354_06184a4a-2e68-4ec7-93b0-637d75ea1d1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA074655
Marketing category ANDA
Marketing start 1997-10-22
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 E
Listing certified through 2017-12-31
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 · 30 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 package package 0615-1354-39 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 package package 0615-1354-39 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 package package 0615-1354-39 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 package package 0615-1354-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-1354-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-1354-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-1354-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-1354-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-1354-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-1354-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-1354-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-1354-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-1354-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-1354-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-1354-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A074655-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 A074655-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2