Ranitidine Hydrochloride

Product NDC
0781-1884
11-digit product format
007811884
Labeler code
0781
Product ID
0781-1884_b913def8-10c9-4651-82dc-a714decc1218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074467
Marketing category
ANDA
Marketing start
1997-08-29
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-1884DDiscontinued by firm2026-08-17
excluded packagepackage0781-18840781-1884-10DDiscontinued by firm2026-08-17
excluded packagepackage0781-18840781-1884-25DDiscontinued by firm2026-08-17
excluded packagepackage0781-18840781-1884-31DDiscontinued by firm2026-08-17

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 1 · 48 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 packagepackage0781-1884-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-1884-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-1884-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1884-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1884-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-1884-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1884-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1884-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-1884-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1884-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1884-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-1884-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1884-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1884-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-1884-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1884-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1884-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-1884-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1884-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1884-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-1884-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1884-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1884-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-1884-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1884-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1884-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-1884-310efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1884-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1884-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-1884-31ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1884-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1884-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-1884-31367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1884-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1884-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-1884-31557ba5c1ecfa…9c80585c8c6e…

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
A074467-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29
A074467-002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074467-001AB
A074467-002AB

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 06:07:402026-07A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074467-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORALAB1997-08-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074467-002RANITIDINE HYDROCHLORIDEEQ 300MG BASETABLET / ORALAB1997-08-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074467-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074467-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074467-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074467-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074467-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074467-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074467-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074467-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074467-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074467-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074467-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074467-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074467-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074467-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074467-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074467-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074467-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074467-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074467-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074467-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074467-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074467-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074467-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074467-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074467-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074467-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074467-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074467-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074467-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074467-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074467-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074467-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074467-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074467-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074467-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074467-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074467-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074467-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074467-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074467-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1884-25EA - Each0781-1884e15503e4-deae-43bc-ba95-756939cff69812012-07-24
0781-1884-31EA - Each0781-1884639ca260-9f91-405b-9410-c32b5f4f059112012-07-24