Ranitidine

Product NDC
49035-353
11-digit product format
490350353
Labeler code
49035
Product ID
49035-353_eab45a8e-bc72-42d0-86f9-2eaef2b1e7b3
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores, Inc
Application
ANDA201745
Marketing category
ANDA
Marketing start
2012-07-10
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
75 mg/1
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-353IInactivated by FDA2026-08-17
excluded packagepackage49035-35349035-353-30IInactivated by FDA2026-08-17
excluded packagepackage49035-35349035-353-55IInactivated by FDA2026-08-17
excluded packagepackage49035-35349035-353-69IInactivated 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 2 · 84 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 packagepackage49035-353-69d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-353-55d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-353-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-353-69f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-353-55f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-353-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-353-692ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-353-552ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-353-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-353-69a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-353-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-353-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-353-69cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-353-55cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-353-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-353-69cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-353-55cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-353-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-353-69302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-353-55302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-353-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-353-69ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-353-55ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-353-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-353-690efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-353-550efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-353-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-353-69ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-353-55ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-353-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-353-69367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-353-55367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-353-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-353-69557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-353-55557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-353-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49035-353-698af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49035-353-558af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49035-353-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49035-353-69834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49035-353-55834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49035-353-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49035-353-691332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49035-353-551332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49035-353-301332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201745-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29

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 06:07:402026-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293f01610625f2…
2019-09-15 20:21 UTC2019-09A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29e64feba35796…

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
49035-353-302020-01-31C16284748780-19d75b9cf-d5dd-f424-e053-dadaa90a57ceDrug Facts
49035-353-552020-01-31C16284748780-19d75b9cf-d5dd-f424-e053-dadaa90a57ceDrug Facts
49035-353-692020-01-31C16284748780-19d75b9cf-d5dd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-353-30Ranitidine30 in 1 BOTTLETABLET, FILM COATED302
49035-353-55Ranitidine150 in 1 BOTTLETABLET, FILM COATED1502
49035-353-69Ranitidine10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-353RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC]2Legacy NDC, 3 package rows20150210_f39319e4-f60e-451f-ba5b-a26462db9bf1.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
Acid ReducerRANITIDINE HYDROCHLORIDEWinCo Foods, LLC70bc7062-ab3c-43eb-b524-0d8c6d1a674d2014-12-10WarningsExact identifier
application applno (ANDA): 201745
application number: ANDA201745

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSNf39319e4-f60e-451f-ba5b-a26462db9bf12
312773ranitidine 75 MG Oral TabletSCDf39319e4-f60e-451f-ba5b-a26462db9bf12
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSYf39319e4-f60e-451f-ba5b-a26462db9bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49035-353-304903503533030 in 1 BOTTLEHistorical
49035-353-5549035035355150 in 1 BOTTLEHistorical
49035-353-694903503536910 in 1 BLISTER PACKHistorical