FDA.reportPublic FDA data

Application 075576

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075576-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21
A075576-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A075576-003OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075576-001AB
A075576-002AB
A075576-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21a50c72e98297…
2026-08-01 22:54:322026-06A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22a50c72e98297…
2026-08-01 22:54:322026-06A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075576-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075576-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075576-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy1eb57c13-25ed-70bc-e063-6294a90afdac2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCaae3bf9f-5d05-889f-e053-2995a90a5ff22025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dcf0b2-4fa2-023a-e053-2995a90a183a2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQuallent Pharmaceuticals Health LLC665e9877-85ac-fdb6-54ac-1c47941ceab82025-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
ndc (product): 82009-022
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.e235ef89-3592-4ca1-8c13-d7ce84b1001c2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEAmerican Health Packaginga17e415e-a559-4a8d-a455-699184a015232025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
ndc (product): 68084-128
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85e324-ef9f-196c-e053-2995a90a384e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
ndc (product): 80425-0071
OmeprazoleOMEPRAZOLEQuality Care Products, LLC581d1c3d-457a-41f2-8db0-5b6219cdcb092024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEProficient Rx LPf0f61a89-700d-481d-9255-6f9a9afa70252024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
ndc (product): 63187-805
OmeprazoleOMEPRAZOLEAdvanced Rx of Tennessee, LLC1d4ecc1e-5180-f75e-e063-6394a90a51a62024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEBryant Ranch Prepacke1f20429-cfaa-420b-a65a-271be37eb7992024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
ndc (product): 71335-0332
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited72fb11b6-b08c-2f02-d82b-f60f523949032024-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEA-S Medication Solutionsb129fe93-c8a2-4ae8-ad1b-8f9ae5779b682023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthStar Rx LLCc5af5f4b-17be-7245-b281-f27c878312422023-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 148 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55154-6648OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-8191OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-8191OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-8191OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-8191OmeprazoleOmeprazoleCardinal Health 107, LLCANDACurrent
58118-0158OmeprazoleOmeprazoleClinical Solutions WholesaleANDACurrent
58118-0158OmeprazoleOmeprazoleClinical Solutions WholesaleANDACurrent
58118-0158OmeprazoleOmeprazoleClinical Solutions WholesaleANDACurrent
63187-805OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-805OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-805OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-805OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63629-3643OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-3643OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-3643OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-3643OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-4358OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
64725-0158OmeprazoleOmeprazoleTYA PharmaceuticalsANDACurrent
67296-0706OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
67296-0706OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
67296-0706OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
68071-2180OmeprazoleOmeprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2180OmeprazoleOmeprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2180OmeprazoleOmeprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2180OmeprazoleOmeprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4051OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4051OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4051OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68084-128OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-128OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-128OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-128OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-128OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-466OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-466OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-466OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68084-466OmeprazoleOmeprazoleAmerican Health PackagingANDACurrent
68788-1554OmeprazoleOmeprazolePreferred Pharmaceuticals, Inc.ANDACurrent
69181-158OmeprazoleOmeprazoleMidwest Drug Distribution, Inc.ANDACurrent
70518-0056OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0056OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0080OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0080OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0080OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0080OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0080OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0080OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0080OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0754OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0754OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1209OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1209OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70934-118OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-118OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-773OmeprazoleOmeprazoleDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0332OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0332OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0332OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0332OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
75921-158OmeprazoleOmeprazoleLife Line Home Care Services, Inc.ANDACurrent
80175-0715OmeprazoleOmeprazoleCentral PackagingANDACurrent
80175-0715OmeprazoleOmeprazoleCentral PackagingANDACurrent
80425-0071PrilosecOmeprazole 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0071PrilosecOmeprazole 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0071OmeprazoleOmeprazoleAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0071OmeprazoleOmeprazoleAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0071OmeprazoleOmeprazoleAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
82009-022OmeprazoleOmeprazoleQuallent Pharmaceuticals Health LLCANDACurrent