Ranitidine

Product NDC
42291-725
11-digit product format
422910725
Labeler code
42291
Product ID
42291-725_a3419a0f-f911-521a-e053-2995a90a4ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA077824
Marketing category
ANDA
Marketing start
2014-08-18
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct42291-725DDiscontinued by firm2026-08-17
excluded packagepackage42291-72542291-725-01DDiscontinued by firm2026-08-17
excluded packagepackage42291-72542291-725-25DDiscontinued by firm2026-08-17
excluded packagepackage42291-72542291-725-30DDiscontinued 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 · 48 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 packagepackage42291-725-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-725-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-725-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-725-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-725-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-725-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-725-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-725-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-725-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-725-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-725-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-725-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-725-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-725-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-725-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-725-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-725-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-725-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-725-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-725-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-725-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-725-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-725-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-725-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-725-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-725-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-725-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-725-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-725-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-725-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-725-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-725-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-725-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-725-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-725-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-725-30557ba5c1ecfa…9c80585c8c6e…

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
A077824-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13
A077824-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13

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 06:07:402026-07A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13caaa826d4ba7…
2026-08-18 06:07:402026-07A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB2006-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALABRS2006-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077824-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2006-10-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077824-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2006-10-13bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077824-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077824-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077824-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077824-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077824-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077824-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077824-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077824-002AB1ea99ee380514…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-725-01EA - Each42291-725219b687c-9f1e-451f-bf19-f0948f8f5cc412014-09-03
42291-725-25EA - Each42291-725374adef4-9ca6-46b9-b80a-42e061f7860012014-09-03
42291-725-30EA - Each42291-7253a51e7b5-7846-4b06-8c5e-1d6e5b3aca5512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [AVKARE, INC.]3
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [AVKARE, INC.]3
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [AVKARE, INC.]3
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [AVKARE, INC.]3
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GRANITIDINE TABLET [AVKARE, INC.]3
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE TABLET [AVKARE, INC.]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [AVKARE, INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [AVKARE, INC.]3
PolydextroseINACTIVE INGREDIENTVH2XOU12IERANITIDINE TABLET [AVKARE, INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [AVKARE, INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [AVKARE, INC.]3
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE TABLET [AVKARE, INC.]3

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
RanitidineRANITIDINEAmneal Pharmaceuticals of New York LLCb38a3332-5c54-453f-aeb7-070f830955c22026-05-01Adverse reactionsExact identifier
application applno (ANDA): 077824
application number: ANDA077824

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG Oral TabletPSN7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198191ranitidine 150 MG Oral TabletSCD7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG Oral TabletSCD7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY7f3348a9-ce69-48d6-89f4-5c0e7d38a2552