Ranitidine

Product NDC
0440-8305
11-digit product format
004408305
Labeler code
0440
Product ID
0440-8305_3410c954-c270-42cc-975d-90d9a0a9e315
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
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
2018-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0440-8305IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-00IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-05IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-20IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-30IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-60IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-81IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-85IInactivated by FDA2026-08-17
excluded packagepackage0440-83050440-8305-90IInactivated 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 4 · 198 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 packagepackage0440-8305-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-8305-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-8305-81d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-8305-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-8305-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-8305-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-8305-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-8305-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-81f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-8305-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-812ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-8305-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-81a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-8305-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-85cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-81cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-8305-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-85cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-81cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-8305-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-8305-85302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-8305-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-8305-81302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-8305-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-8305-30302b2466d912…e7b80fea0513…

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
0440-8305-00Ranitidine1000 in 1 BOTTLETABLET10001
0440-8305-05Ranitidine500 in 1 BOTTLETABLET5001
0440-8305-20Ranitidine20 in 1 BOTTLETABLET201
0440-8305-30Ranitidine30 in 1 BOTTLETABLET301
0440-8305-60Ranitidine60 in 1 BOTTLETABLET601
0440-8305-81Ranitidine300 in 1 BOTTLETABLET3001
0440-8305-85Ranitidine800 in 1 BOTTLETABLET8001
0440-8305-90Ranitidine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8305RANITIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 8 package rows20160729_ae8c3e95-3503-4553-bc58-cc3e0170bcf8.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 TabletPSNae8c3e95-3503-4553-bc58-cc3e0170bcf81
198191ranitidine 150 MG Oral TabletSCDae8c3e95-3503-4553-bc58-cc3e0170bcf81
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYae8c3e95-3503-4553-bc58-cc3e0170bcf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8305-00004408305001000 in 1 BOTTLEHistorical
0440-8305-0500440830505500 in 1 BOTTLEHistorical
0440-8305-200044083052020 in 1 BOTTLEHistorical
0440-8305-300044083053030 in 1 BOTTLEHistorical
0440-8305-600044083056060 in 1 BOTTLEHistorical
0440-8305-8100440830581300 in 1 BOTTLEHistorical
0440-8305-8500440830585800 in 1 BOTTLEHistorical
0440-8305-900044083059090 in 1 BOTTLEHistorical