Ranitidine

Product NDC
21695-109
11-digit product format
216950109
Labeler code
21695
Product ID
21695-109_dcee67ac-e58c-4050-ad16-f8253a17036b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-17
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
E
Listing certified through
2017-12-31
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 productproduct21695-109IInactivated by FDA2026-08-17
excluded packagepackage21695-10921695-109-00IInactivated by FDA2026-08-17
excluded packagepackage21695-10921695-109-14IInactivated by FDA2026-08-17
excluded packagepackage21695-10921695-109-30IInactivated by FDA2026-08-17
excluded packagepackage21695-10921695-109-60IInactivated by FDA2026-08-17
excluded packagepackage21695-10921695-109-72IInactivated by FDA2026-08-17
excluded packagepackage21695-10921695-109-90IInactivated 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 3 · 154 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 packagepackage21695-109-72d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-109-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-109-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-109-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-109-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-109-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-109-72f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-109-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-109-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-109-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-109-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-109-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-109-722ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-109-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-109-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-109-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-109-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-109-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-109-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-109-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-109-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-109-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-109-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-109-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-109-72cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-109-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-109-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-109-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-109-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-109-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-109-72cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-109-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-109-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-109-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-109-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-109-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-109-72302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-109-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-109-00302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-109-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-109-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-109-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-109-72ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-109-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-109-00ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-109-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-109-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-109-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-109-720efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-109-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-109-000efc9e666f02…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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-109-00Ranitidine100 in 1 BOTTLETABLET1001
21695-109-14Ranitidine14 in 1 BOTTLETABLET141
21695-109-30Ranitidine30 in 1 BOTTLETABLET301
21695-109-60Ranitidine60 in 1 BOTTLETABLET601
21695-109-72Ranitidine120 in 1 BOTTLETABLET1201
21695-109-90Ranitidine90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-109-00EA - Each21695-109ee24a758-3437-47eb-b440-104287c5eb9812012-07-24
21695-109-14EA - Each21695-109c0b180a3-2158-48ac-ae51-90a8f3d6044312012-07-24
21695-109-30EA - Each21695-109244162e9-9d5d-47e7-88f7-09c42fa87eaa12012-07-24
21695-109-60EA - Each21695-1092f78467b-8d4c-498d-8328-b326bac4953012012-07-24
21695-109-72EA - Each21695-109feea6f9e-6b5a-4717-8a53-e8605bc3028012012-07-24
21695-109-90EA - Each21695-1092a1aed57-2a36-4efa-860e-a21ee20742f212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-109RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1Legacy NDC, 6 package rows20100216_a9fef8f6-b823-4b8a-84b8-2b916374adb5.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
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 TabletPSNa9fef8f6-b823-4b8a-84b8-2b916374adb51
198193ranitidine 300 MG Oral TabletPSNa9fef8f6-b823-4b8a-84b8-2b916374adb51
198191ranitidine 150 MG Oral TabletSCDa9fef8f6-b823-4b8a-84b8-2b916374adb51
198193ranitidine 300 MG Oral TabletSCDa9fef8f6-b823-4b8a-84b8-2b916374adb51
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYa9fef8f6-b823-4b8a-84b8-2b916374adb51
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYa9fef8f6-b823-4b8a-84b8-2b916374adb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-109-0021695010900100 in 1 BOTTLEHistorical
21695-109-142169501091414 in 1 BOTTLEHistorical
21695-109-302169501093030 in 1 BOTTLEHistorical
21695-109-602169501096060 in 1 BOTTLEHistorical
21695-109-7221695010972120 in 1 BOTTLEHistorical
21695-109-902169501099090 in 1 BOTTLEHistorical