Acid Reducer

Product NDC
61715-090
11-digit product format
617150090
Labeler code
61715
Product ID
61715-090_6ac37537-b020-4981-92ec-825f72a0268c
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Plus (Kinray)
Application
ANDA201745
Marketing category
ANDA
Marketing start
2014-01-27
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
75 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61715-090DDiscontinued by firm2026-08-17
excluded packagepackage61715-09061715-090-30DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61715-090-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61715-090-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61715-090-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61715-090-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61715-090-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61715-090-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61715-090-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61715-090-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61715-090-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61715-090-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61715-090-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61715-090-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61715-090-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61715-090-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61715-090-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61715-090-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61715-090-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61715-090-30IInactivated by FDAbd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201745-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293f01610625f2…
2019-09-15 20:21 UTC2019-09A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201745-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2012-02-29e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61715-090-302025-06-02C16284748780-1d6a99b39-ba90-a426-e053-dadaa90af4c2Drug Facts
61715-090-302022-01-28C16284748780-1d6a99b39-ba90-a426-e053-dadaa90af4c2Drug Facts

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61715-090ACID REDUCER (RANITIDINE) TABLET, FILM COATED [PREFERRED PLUS (KINRAY)]2Legacy NDC20200115_00a6fe2f-d9e6-4d75-9c21-16b40b1da320.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
Acid ReducerRANITIDINE HYDROCHLORIDEWinCo Foods, LLC70bc7062-ab3c-43eb-b524-0d8c6d1a674d2014-12-10WarningsExact identifier
application applno (ANDA): 201745
application number: ANDA201745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61715-090-30617150090303 BLISTER PACK in 1 CARTON (61715-090-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2020-01-150000-00-00NoNoCurrent