Ranitidine

Product NDC
50090-2574
11-digit product format
500902574
Labeler code
50090
Product ID
50090-2574_20fb240d-5072-406e-ab97-96a686a577c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078542
Marketing category
ANDA
Marketing start
2008-11-19
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2574DDiscontinued by firm2026-08-17
excluded packagepackage50090-257450090-2574-0DDiscontinued by firm2026-08-17
excluded packagepackage50090-257450090-2574-1DDiscontinued by firm2026-08-17
excluded packagepackage50090-257450090-2574-2DDiscontinued by firm2026-08-17
excluded packagepackage50090-257450090-2574-5DDiscontinued by firm2026-08-17
excluded packagepackage50090-257450090-2574-7DDiscontinued by firm2026-08-17
excluded packagepackage50090-257450090-2574-9DDiscontinued 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 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 packagepackage50090-2574-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2574-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2574-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2574-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2574-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2574-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2574-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2574-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2574-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2574-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2574-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2574-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2574-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2574-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2574-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2574-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2574-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2574-72ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2574-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2574-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2574-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2574-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2574-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2574-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2574-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2574-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2574-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2574-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2574-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2574-7cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2574-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2574-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2574-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2574-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2574-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2574-7cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2574-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2574-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2574-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2574-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2574-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2574-7302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2574-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2574-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2574-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2574-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2574-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2574-7ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2574-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2574-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2574-50efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078542-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-19
A078542-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-19

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2008-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2008-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078542-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2008-11-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078542-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB2008-11-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A078542-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078542-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078542-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078542-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078542-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078542-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078542-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078542-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078542-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078542-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078542-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078542-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078542-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078542-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078542-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078542-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078542-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078542-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078542-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078542-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078542-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078542-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078542-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078542-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078542-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078542-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078542-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078542-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078542-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078542-002AB15aa47cf7b7d7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2574-0EA - Each50090-2574a6a44933-8bad-499c-854c-47bce2a8a69d12019-04-11
50090-2574-1EA - Each50090-25748c1d6fa8-d9b5-47fd-9710-c317088c290812018-11-06
50090-2574-2EA - Each50090-2574bafd6d03-3f8f-4364-b954-800c773e4d2f12018-11-06
50090-2574-5EA - Each50090-2574b156946e-9d2c-49a6-9795-2cb0a1feeaf612018-11-06
50090-2574-7EA - Each50090-25740cea93b3-2e79-494f-8800-b6d88c0e12e712018-11-06
50090-2574-9EA - Each50090-2574166c6cf7-ace7-4ef0-9513-b77858db028b12018-11-06