Home NDC 55111-131-04 Ranitidine
Product NDC 55111-131
Requested package NDC 55111-131-04
11-digit product format 551110131
Labeler code 55111
Product ID 55111-131_210e3c0b-be93-aa50-550d-e383e7d5f19e
Type HUMAN OTC DRUG
Nonproprietary name Ranitidine
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA075294
Marketing category ANDA
Marketing start 2000-03-01
Substance RANITIDINE HYDROCHLORIDE
Active strength 75 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075294-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28
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 2 · 42 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 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075294-001 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2000-03-28 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Ranitidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RANITIDINE HYDROCHLORIDE 75 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312773 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 ranitidine hydrochloride ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 CETIRIZINE ACTIVE MOIETY YO7261ME24 ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 ranitidine ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 POVIDONE INACTIVE INGREDIENT FZ989GH94E ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [WAL-MART STORES INC] 6 ranitidine hydrochloride ACTIVE INGREDIENT BK76465IHM WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 ranitidine ACTIVE MOIETY 884KT10YB7 WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP WAL-ZAN 75 (RANITIDINE TABLET USP, 75MG) TABLET [WALGREENS COMPANY] 2 ranitidine hydrochloride ACTIVE INGREDIENT BK76465IHM RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 ranitidine hydrochloride ACTIVE INGREDIENT BK76465IHM RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1 ranitidine hydrochloride ACTIVE INGREDIENT BK76465IHM RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 ranitidine ACTIVE MOIETY 884KT10YB7 RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1 ranitidine ACTIVE MOIETY 884KT10YB7 RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 ranitidine ACTIVE MOIETY 884KT10YB7 RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE 75 (RANITIDINE TABLETS) TABLET [MEIJER DISTRIBUTION INC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [THE KROGER CO.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE 75 (RANITIDINE TABLETS USP, 75MG) TABLET [TARGET BRANDS INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-131 RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 Current NDC, Legacy NDC 20250529_12a38e29-130c-6d41-1753-acccb0b41efe.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 55111-131-04 55111013104 1 BOTTLE in 1 CARTON (55111-131-04) / 120 TABLET in 1 BOTTLE 1 bottle 2000-03-01 0000-00-00 No No Current