FDA.reportPublic FDA data

Application 078878

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMCAPSULE, DELAYED RELEASE;ORALEQ 20MG BASENoYes

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
A078878-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05

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 UTC2022-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMGericare Pharmaceuticals0e1f5d7c-5956-3be7-e054-00144ff8d46c2025-07-28WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 57896-759
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMHEB5d8b3f5f-f680-64ae-b360-c0bd06b2ac922025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 37808-006
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMCVS Health Corp.3bbfa87d-f8b7-19bd-9f12-39cba31ae0b32025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 69842-027
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationab5d339b-2c02-611d-d5db-8e1891684fe02025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Acid ReducerOMEPRAZOLE MAGNESIUMLEADER/ Cardinal Health 110, Inc.1dc00f13-d1f5-15a0-32cc-4fc041865e722025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 70000-0232
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMAlbertsons Companies302b1332-181b-834b-4154-d849cb3a1ef02025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 21130-398
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Incdaeeba93-29d5-efb4-a591-3e72c4e503412025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 53943-520
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESThe Kroger Co.8a6bbc31-7c50-a730-4233-e346fd7eb5ba2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 30142-012
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.fe0eb905-2042-aed1-a67d-a219e76f679b2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 43598-813
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMWalgreens Companyee8b1740-9bcf-5b70-bd8d-97f98303dc722025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 0363-0042
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESWal-Mart Stores Inc3160e212-9ee9-8316-f51e-4628862f654c2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 49035-397
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Consortium, LLC39ac65c0-d957-125f-f00b-e3846a4374892025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 68016-760
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationfdf1259b-e9d3-70a9-c209-e2eb6b1528412025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 63868-177
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited0e8fde83-a55c-edaf-3c66-e1fc77d0bc112025-05-28WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
ndc (product): 55111-397

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 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-8104Omeprazole MagnesiumOmeprazole MagnesiumKaiser PermanenteANDACurrent
0179-8104Omeprazole MagnesiumOmeprazole MagnesiumKaiser PermanenteANDACurrent
0363-0042Omeprazole MagnesiumOmeprazole MagnesiumWalgreens CompanyANDACurrent
11673-397Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesTarget CorporationANDACurrent
21130-398Omeprazole MagnesiumOmeprazole MagnesiumAlbertsons CompaniesANDACurrent
30142-012Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesThe Kroger Co.ANDACurrent
37808-006Omeprazole MagnesiumOmeprazole MagnesiumHEBANDACurrent
37835-891Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMBi-MartANDACurrent
41250-064Omeprazole MagnesiumOmeprazole MagnesiumMeijer Distribution IncANDACurrent
43598-813Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories Inc.ANDACurrent
49035-397Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesWal-Mart Stores IncANDACurrent
53943-520Omeprazole MagnesiumOmeprazole MagnesiumDiscount Drug Mart, IncANDACurrent
53943-520Omeprazole MagnesiumOmeprazole MagnesiumDiscount Drug Mart, IncANDACurrent
55111-397Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories LimitedANDACurrent
55111-397Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories LimitedANDACurrent
55111-397Omeprazole MagnesiumOmeprazole MagnesiumDr. Reddy's Laboratories LimitedANDACurrent
55315-367Omeprazole MagnesiumOmeprazole MagnesiumFREDSANDACurrent
55315-368Omeprazole MagnesiumOmeprazole MagnesiumFREDSANDACurrent
55319-916Omeprazole MagnesiumOmeprazole MagnesiumFamily Dollar Stores, Inc.ANDACurrent
57896-759Omeprazole MagnesiumOmeprazole MagnesiumGericare PharmaceuticalsANDACurrent
57896-759Omeprazole MagnesiumOmeprazole MagnesiumGericare PharmaceuticalsANDACurrent
59450-012Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesThe Kroger Co.ANDACurrent
59450-012Omeprazole MagnesiumOmeprazole Magnesium 20.6mg CapsulesThe Kroger Co.ANDACurrent
63868-177Omeprazole MagnesiumOmeprazole MagnesiumChain Drug Marketing AssociationANDACurrent
68016-759OmeprazoleOmeprazoleChain Drug Consortium, LLCANDACurrent
68016-759OmeprazoleOmeprazoleChain Drug Consortium, LLCANDACurrent
68016-760Omeprazole MagnesiumOmeprazole MagnesiumChain Drug Consortium, LLCANDACurrent
69618-047OmeprazoleOmeprazoleReliable 1 Laboratories LLCANDACurrent
69618-047OmeprazoleOmeprazoleReliable 1 Laboratories LLCANDACurrent
69618-047OmeprazoleOmeprazoleReliable 1 Laboratories LLCANDACurrent
69842-027Omeprazole MagnesiumOmeprazole MagnesiumCVS Health Corp.ANDACurrent
70000-0232Acid ReducerOmeprazole MagnesiumCardinal HealthANDACurrent
70000-0232Acid ReducerOmeprazole MagnesiumCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43150ORIG2013-05-10