RANITIDINE

Product NDC
64679-906
Requested package NDC
64679-906-06
11-digit product format
646790906
Labeler code
64679
Product ID
64679-906_76bec459-49be-4132-843c-6f471dab81a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA075208
Marketing category
ANDA
Marketing start
1998-12-17
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
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64679-90664679-906-06DDiscontinued 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 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

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
A075208-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17
A075208-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17

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 22:38:342026-08A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-1784e616aacf4f…
2026-09-14 22:38:342026-08A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-1784e616aacf4f…
2026-08-18 06:07:402026-07A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL1998-12-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORAL1998-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075208-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1998-12-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075208-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1998-12-1774a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075208-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075208-002AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A075208-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075208-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075208-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075208-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075208-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075208-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075208-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075208-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075208-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075208-002AB1ea99ee380514…

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
64679-906-012024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-022024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-032024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-042024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-052024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-062024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-112024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-122024-11-06Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-012022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-022022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-032022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-042022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-052022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-062022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-112022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
64679-906-122022-07-29Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-906-01EA - Each64679-906de5a94da-ed5d-453a-bf6c-94201ed7984c12012-07-24
64679-906-03EA - Each64679-906db9436b8-a09d-4a76-a7f2-02569fc75f2412012-07-24
64679-906-06EA - Each64679-90659dde69b-5d31-4f1d-9d8d-40f5050c477f12012-07-24
64679-906-11EA - Each64679-90625766929-6368-4c32-a803-213237c5ab1012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GRANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [WOCKHARDT USA LLC]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [WOCKHARDT USA LLC]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GRANITIDINE TABLET [WOCKHARDT USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [WOCKHARDT USA LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [WOCKHARDT USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [WOCKHARDT USA LLC]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [WOCKHARDT USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [WOCKHARDT USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE TABLET [WOCKHARDT USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [WOCKHARDT USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN7de06786-bf44-4928-aa69-47ab71f276332
198193ranitidine 300 MG Oral TabletPSN7de06786-bf44-4928-aa69-47ab71f276332
198191ranitidine 150 MG Oral TabletSCD7de06786-bf44-4928-aa69-47ab71f276332
198193ranitidine 300 MG Oral TabletSCD7de06786-bf44-4928-aa69-47ab71f276332
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY7de06786-bf44-4928-aa69-47ab71f276332
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY7de06786-bf44-4928-aa69-47ab71f276332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-906-0664679090606100 TABLET in 1 BOTTLE (64679-906-06) 100 tablet1998-12-170000-00-00NoNoCurrent