RANITIDINE

Product NDC
64679-447
11-digit product format
646790447
Labeler code
64679
Product ID
64679-447_c63eb133-3d21-4f57-a3a4-07e8f59fe6a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
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 productproduct64679-447DDiscontinued by firm2026-10-05
excluded packagepackage64679-44764679-447-01DDiscontinued by firm2026-10-05
excluded packagepackage64679-44764679-447-02DDiscontinued by firm2026-10-05
excluded packagepackage64679-44764679-447-03DDiscontinued by firm2026-10-05
excluded packagepackage64679-44764679-447-04DDiscontinued by firm2026-10-05
excluded packagepackage64679-44764679-447-05DDiscontinued by firm2026-10-05
excluded packagepackage64679-44764679-447-06DDiscontinued by firm2026-10-05
excluded packagepackage64679-44764679-447-07DDiscontinued by firm2026-10-05

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 packagepackage64679-447-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-447-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-447-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-447-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-447-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-447-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-447-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-447-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-447-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-447-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-447-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-447-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-447-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-447-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-447-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-447-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-447-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-447-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-447-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-447-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-447-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-447-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-447-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-447-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-447-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-447-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-447-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-447-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-447-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-447-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-447-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-447-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-447-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-447-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-447-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-447-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-447-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-447-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-447-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-447-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-447-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-447-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-447-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-447-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-447-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-447-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-447-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-447-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-447-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-447-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-447-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-447-06ed331223b511…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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-447-02EA - Each64679-447b1b167a2-c6eb-4fb1-8b97-4f8b7b2bcff612012-07-24
64679-447-04EA - Each64679-4475f485bf3-a5ac-40a0-8391-aff0f68bc43312012-07-24
64679-447-06EA - Each64679-44724184f94-a176-4ab6-916a-7f8175ca06a612012-07-24

DailyMed Socrata Ingredients#