FDA.reportPublic FDA data

Application 075294

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 75MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075294-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28a50c72e98297…

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
RanitidineRANITIDINEDr. Reddy's Laboratories Limited12a38e29-130c-6d41-1753-acccb0b41efe2025-05-23WarningsExact identifier
application applno (ANDA): 075294
application number: ANDA075294
ndc (product): 55111-131

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0131Wal-Zan 75Ranitidine Tablet USP, 75mgWalgreens CompanyANDACurrent
0363-0131Wal-Zan 75Ranitidine Tablet USP, 75mgWalgreens CompanyANDACurrent
0904-6921RanitidineRanitidineMAJOR PHARMACEUTICALSANDACurrent
0904-6921RanitidineRanitidineMAJOR PHARMACEUTICALSANDACurrent
11673-131Ranitidine 75Ranitidine Tablets USP, 75mgTarget Brands IncANDACurrent
30142-131Ranitidine 75Ranitidine Tablets USP, 75mgThe Kroger Co.ANDACurrent
30142-131Ranitidine 75Ranitidine Tablets USP, 75mgThe Kroger Co.ANDACurrent
41250-131Ranitidine 75Ranitidine TabletsMeijer Distribution IncANDACurrent
53943-740HEARTBURN RELIEVER 75RanitidineDiscount Drug MartANDACurrent
53943-740HEARTBURN RELIEVER 75RanitidineDiscount Drug MartANDACurrent
53943-740HEARTBURN RELIEVER 75RanitidineDiscount Drug MartANDACurrent
55111-131RanitidineRanitidineDr. Reddy's Laboratories LimitedANDACurrent
55111-131RanitidineRanitidineDr. Reddy's Laboratories LimitedANDACurrent
57896-715ACID REDUCERRanitidineGERI-CARE PHARMACEUTICAL CORPANDACurrent
57896-715ACID REDUCERRanitidineGERI-CARE PHARMACEUTICAL CORPANDACurrent
63868-482RanitidineRanitidineChain Drug Marketing AssociationANDACurrent
63868-482RanitidineRanitidineChain Drug Marketing AssociationANDACurrent
68071-5012ACID REDUCERRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5012ACID REDUCERRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
69842-871Acid ReducerRanitidineCVS HEALTH CORPANDACurrent
69842-871Acid ReducerRanitidineCVS HEALTH CORPANDACurrent
70000-0033RanitidineRanitidineCARDINAL HEALTHANDACurrent
70000-0033RanitidineRanitidineCARDINAL HEALTHANDACurrent
70000-0033RanitidineRanitidineCARDINAL HEALTHANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30837ORIG2004-06-14
30838ORIG2000-03-28