Home NDC 53746-254 Ranitidine
Product NDC 53746-254
11-digit product format 537460254
Labeler code 53746
Product ID 53746-254_906b462d-e4a3-4f23-8d1b-2605476c40e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA077824
Marketing category ANDA
Marketing start 2009-12-16
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 2027-12-31
Current FDA listing Yes 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# Additional Listing Data#
Finished product Yes
Brand name base Ranitidine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RANITIDINE HYDROCHLORIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BK76465IHM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198191 Internal RxNorm lookup 198193 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 53746-254-01 Ranitidine 100 in 1 BOTTLE TABLET 100 21 53746-254-02 Ranitidine 250 in 1 BOTTLE TABLET 250 21 53746-254-30 Ranitidine 30 in 1 BOTTLE TABLET 30 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 15 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 15 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM RANITIDINE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 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 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [STAT RX USA LLC] 2 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [STAT RX USA LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE TABLET [STAT RX USA LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RANITIDINE TABLET [STAT RX USA LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RANITIDINE TABLET [STAT RX USA LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE TABLET [STAT RX USA LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE TABLET [STAT RX USA LLC] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE RANITIDINE TABLET [STAT RX USA LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE TABLET [STAT RX USA LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE TABLET [STAT RX USA LLC] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM RANITIDINE TABLET [STAT RX USA LLC] 2 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS] 1 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-254 RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 19 Current NDC, Legacy NDC, 3 package rows 20230112_b38a3332-5c54-453f-aeb7-070f830955c2.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 53746-254-01 53746025401 100 TABLET in 1 BOTTLE (53746-254-01) 100 tablet 2009-12-16 0000-00-00 No No Current 53746-254-02 53746025402 250 TABLET in 1 BOTTLE (53746-254-02) 250 tablet 2009-12-16 0000-00-00 No No Current 53746-254-30 53746025430 30 TABLET in 1 BOTTLE (53746-254-30) 30 tablet 2009-12-16 0000-00-00 No No Current