Home NDC 67296-1586-6 Ranitidine
Product NDC 67296-1586
Requested package NDC 67296-1586-6
11-digit product format 672961586
Labeler code 67296
Product ID 67296-1586_d61c14b0-7134-21ce-e053-2a95a90af133
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine
Dosage form SYRUP
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA077405
Marketing category ANDA
Marketing start 2018-01-01
Marketing end 0000-00-00
Substance RANITIDINE
Active strength 15 mg/mL
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 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 A077405-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21
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 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL 2007-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077405-001 RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP / ORAL AA RS 2007-09-21 e64feba35796…
Observed Orange Book normalized TE history# 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 67296-1586-6 Ranitidine 60 mL in 1 BOTTLE SYRUP 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1586 RANITIDINE SYRUP [REDPHARM DRUG, INC.] 4 Legacy NDC, 1 package rows 20220122_6a10f978-be03-1362-e053-2991aa0a4c1f.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 67296-1586-6 67296158606 60 mL in 1 BOTTLE (67296-1586-6) 60 ml 2018-01-01 0000-00-00 No No Current