Ranitidine

Product NDC
50436-0727
11-digit product format
504360727
Labeler code
50436
Product ID
50436-0727_2bfa140c-ef83-4762-abf8-c6ae13ae388a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANITIDINE
Dosage form
SYRUP
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077405
Marketing category
ANDA
Marketing start
2010-11-01
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
15 mg/mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-0727IInactivated by FDA2026-08-17
excluded packagepackage50436-072750436-0727-1IInactivated by FDA2026-08-17

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-0727-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-0727-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-0727-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-0727-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-0727-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-0727-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-0727-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-0727-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-0727-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-0727-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-0727-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-0727-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-0727-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-0727-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-0727-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-0727-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-0727-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-0727-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-0727-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50436-0727-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50436-0727-19bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077405-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORAL2007-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-213f01610625f2…
2019-09-15 20:21 UTC2019-09A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077405-001RANITIDINE HYDROCHLORIDEEQ 15MG BASE/MLSYRUP / ORALAARS2007-09-21e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077405-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077405-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077405-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077405-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077405-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077405-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077405-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A077405-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077405-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077405-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077405-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A077405-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077405-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077405-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077405-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077405-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077405-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077405-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077405-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077405-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077405-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077405-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077405-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077405-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077405-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077405-001AA1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0727-12020-01-31C16284748780-19d75b9d0-ab67-f424-e053-dadaa90a57ceRanitidine Syrup (Ranitidine Oral Solution USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0727-1Ranitidine1 mL in 1 BOTTLESYRUP12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0727RANITIDINE SYRUP [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20180620_817c4a6c-a89c-4d86-87a3-895bbc8fb4ad.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RanitidineRANITIDINEPharmaceutical Associates, Inc.d0da9dd6-c691-4614-99c7-531b0bf348372022-01-12Adverse reactionsExact identifier
application applno (ANDA): 077405
application number: ANDA077405

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705610ranitidine 15 MG/ML Oral SolutionSCD817c4a6c-a89c-4d86-87a3-895bbc8fb4ad2
705610ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral SolutionSY817c4a6c-a89c-4d86-87a3-895bbc8fb4ad2
705610ranitidine 75 MG per 5 ML SyrupSY817c4a6c-a89c-4d86-87a3-895bbc8fb4ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-0727-1504360727011 mL in 1 BOTTLE1 mlHistorical