FDA.reportPublic FDA data

Application 078192

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG 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
A078192-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31

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 UTC2022-10A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078192-001RANITIDINE HYDROCHLORIDEEQ 150MG BASETABLET / ORAL2007-08-31a50c72e98297…

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 Limited00df8a42-296f-80dd-98af-ee8b30eb38cc2025-05-23WarningsExact identifier
application applno (ANDA): 078192
application number: ANDA078192
ndc (product): 55111-404

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0010Wal-ZanRanitidine Hydrochloride Tablets 150mgWalgreens CompanyANDACurrent
11673-849RanitidineRanitidineTarget CorporationANDACurrent
21130-404Acid Reducer 150Ranitidine Hydrochloride Tablets 150mgSafeway IncANDACurrent
30142-505Heratburn ReliefRanitidineThe Kroger Co.ANDACurrent
43598-808RanitidineRanitidineDr. Reddy's Laboratories Inc.ANDACurrent
49035-404Ranitidine 150Ranitidine Hydrochloride Tablets 150mgWalmart Stores Inc.ANDACurrent
53943-741HEARTBURN RELIEVER 150RanitidineDiscount Drug MartANDACurrent
53943-741HEARTBURN RELIEVER 150RanitidineDiscount Drug MartANDACurrent
53943-741HEARTBURN RELIEVER 150RanitidineDiscount Drug MartANDACurrent
55111-404RanitidineRanitidineDr. Reddy's Laboratories LimitedANDACurrent
55111-404RanitidineRanitidineDr. Reddy's Laboratories LimitedANDACurrent
55111-404RanitidineRanitidineDr. Reddy's Laboratories LimitedANDACurrent
57896-717ACID REDUCERRanitidineGERI-CARE PHARMACEUTICAL CORPANDACurrent
57896-717ACID REDUCERRanitidineGERI-CARE PHARMACEUTICAL CORPANDACurrent
63868-480RanitidineRanitidineChain Drug Marketing AssociationANDACurrent
68196-985RanitidineRanitidineSam's West IncANDACurrent
68998-375Ranitidine 150Ranitidine HCl Tablets 150mgMarc Glassman, Inc.ANDACurrent
68998-397Ranitidine 150Ranitidine HCl Tablets 150mgMarc Glassman, Inc.ANDACurrent
69168-375Ranitidine 150Ranitidine Hydrochloride Tablets 150mgAllegiant HealthANDACurrent
69168-375Ranitidine 150Ranitidine Hydrochloride Tablets 150mgAllegiant HealthANDACurrent
69168-389Ranitidine 150Ranitidine Hydrochloride Tablets 150mgAllegiant HealthANDACurrent
69168-902Ranitidine 150Ranitidine HCl Tablets 150mgAllegiant HealthANDACurrent
69842-869Acid ReducerRanitidineCVS HEALTH CORPANDACurrent
71713-203RanitidineRanitidineThirty Madison IncANDACurrent
71713-203RanitidineRanitidineThirty Madison IncANDACurrent