Ranitidine 150

Product NDC
49035-404
Requested package NDC
49035-404-61
11-digit product format
490350404
Labeler code
49035
Product ID
49035-404_d109f800-f9dc-6667-fbae-7929c4d1c8d3
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride Tablets 150mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Walmart Stores Inc.
Application
ANDA078192
Marketing category
ANDA
Marketing start
2010-01-05
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-40449035-404-61DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A078192-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31

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 06:07:402026-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49035-404-132025-07-24Drug Facts
49035-404-342025-07-24Drug Facts
49035-404-612025-07-24Drug Facts
49035-404-652025-07-24Drug Facts
49035-404-132025-01-30Drug Facts
49035-404-342025-01-30Drug Facts
49035-404-612025-01-30Drug Facts
49035-404-652025-01-30Drug Facts

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-404RANITIDINE 150 (RANITIDINE HYDROCHLORIDE TABLETS 150MG) TABLET, COATED [WALMART STORES INC.]4Legacy NDC20231103_83fd081b-30ae-68b4-5153-20d83caca0c1.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
RanitidineRANITIDINEDr. Reddy's Laboratories Limited00df8a42-296f-80dd-98af-ee8b30eb38cc2025-05-23WarningsExact identifier
application applno (ANDA): 078192
application number: ANDA078192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-404-61490350404611 BOTTLE in 1 CARTON (49035-404-61) > 65 TABLET, COATED in 1 BOTTLE1 bottle2010-01-050000-00-00NoNoCurrent