RANITIDINE

Product NDC
55648-447
11-digit product format
556480447
Labeler code
55648
Product ID
55648-447_fda4671d-cce2-44b4-b41c-caa6ca7ecbec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANITIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA078701
Marketing category
ANDA
Marketing start
2009-12-11
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-447IInactivated by FDA2026-10-05
excluded packagepackage55648-44755648-447-01IInactivated by FDA2026-10-05
excluded packagepackage55648-44755648-447-02IInactivated by FDA2026-10-05
excluded packagepackage55648-44755648-447-03IInactivated by FDA2026-10-05
excluded packagepackage55648-44755648-447-04IInactivated by FDA2026-10-05
excluded packagepackage55648-44755648-447-05IInactivated by FDA2026-10-05
excluded packagepackage55648-44755648-447-06IInactivated by FDA2026-10-05
excluded packagepackage55648-44755648-447-07IInactivated by FDA2026-10-05

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 · 168 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 packagepackage55648-447-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-447-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-447-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-447-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-447-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-447-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-447-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-447-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-447-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-447-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-447-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-447-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-447-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-447-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-447-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-447-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-447-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-447-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-447-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-447-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-447-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-447-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-447-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-447-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-447-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-447-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-447-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-447-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-447-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-447-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-447-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-447-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-447-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-447-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-447-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-447-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-447-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-447-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-447-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-447-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-447-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-447-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-447-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-447-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-447-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-447-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-447-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-447-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-447-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-447-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-447-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-447-04ed331223b511…672a5bd82f5f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078701-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12
A078701-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-1284e616aacf4f…
2026-09-14 22:38:342026-08A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-1184e616aacf4f…
2026-08-18 06:07:402026-07A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078701-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2009-11-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078701-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL2009-12-1174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
55648-447-01RANITIDINE10 in 1 BOTTLETABLET102
55648-447-02RANITIDINE100 in 1 BOTTLETABLET1002
55648-447-03RANITIDINE10 in 1 BLISTER PACKTABLET102
55648-447-03RANITIDINE10 in 1 CARTONTABLET102
55648-447-04RANITIDINE60 in 1 BOTTLETABLET602
55648-447-05RANITIDINE15000 in 1 DRUMTABLET150002
55648-447-06RANITIDINE500 in 1 BOTTLETABLET5002
55648-447-07RANITIDINE6000 in 1 DRUMTABLET60002

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-447RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET [WOCKHARDT LIMITED]2Legacy NDC, 8 package rows20130102_c79c92e0-1e7b-4854-a99a-1a22eed3c333.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNc79c92e0-1e7b-4854-a99a-1a22eed3c3332
198193ranitidine 300 MG Oral TabletPSNc79c92e0-1e7b-4854-a99a-1a22eed3c3332
198191ranitidine 150 MG Oral TabletSCDc79c92e0-1e7b-4854-a99a-1a22eed3c3332
198193ranitidine 300 MG Oral TabletSCDc79c92e0-1e7b-4854-a99a-1a22eed3c3332
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYc79c92e0-1e7b-4854-a99a-1a22eed3c3332
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYc79c92e0-1e7b-4854-a99a-1a22eed3c3332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-447-015564804470110 in 1 BOTTLEHistorical
55648-447-0255648044702100 in 1 BOTTLEHistorical
55648-447-035564804470310 in 1 BLISTER PACKHistorical
55648-447-045564804470460 in 1 BOTTLEHistorical
55648-447-055564804470515000 in 1 DRUMHistorical
55648-447-0655648044706500 in 1 BOTTLEHistorical
55648-447-07556480447076000 in 1 DRUMHistorical