FDA.reportPublic FDA data

NDC 70771-1783-01 - Theophylline

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70771-1783
Requested NDC
70771-1783-01
Package NDCs from labels
70771-1783-1, 70771-1783-01
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Theophylline - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-05-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1783-1Theophylline100 in 1 BOTTLETABLET, EXTENDED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1783THEOPHYLLINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20240528_7339f98d-b996-4e20-a7a7-315fd2a9fa4d.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 3 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
TheophyllineTHEOPHYLLINEChartwell RX, LLC9591d4db-2b88-4f0f-b61e-64ba67626e3d2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 317769
unii: 0I55128JYK
TheophyllineTHEOPHYLLINEATLANTIC BIOLOGICALS CORP.47e484c2-f59e-4a71-bb97-c90f128ac3452025-12-04Warnings, Adverse reactionsExact identifier
unii: 0I55128JYK
Theophylline (Anhydrous)THEOPHYLLINE ANHYDROUSWestminster Pharmaceuticals, LLC04f1d1da-ce61-45b3-acf4-903cc81d16da2025-12-04Warnings, Adverse reactionsExact identifier
unii: 0I55128JYK
TheophyllineTHEOPHYLLINEAjanta Pharma USA Inc.7a422c32-bbdf-4297-84f4-9c438c904b0c2025-11-30Warnings, Adverse reactionsExact identifier
rxcui: 317769
rxcui: 314241
unii: 0I55128JYK
TheophyllineTHEOPHYLLINEChartwell Governmental & Specialty RX, LLC.e2716dac-8b23-4e06-bc3e-4dd76b7c813e2025-11-14Warnings, Adverse reactionsExact identifier
unii: 0I55128JYK
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
TheophyllineTHEOPHYLLINEBryant Ranch Prepack62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd2025-10-22Warnings, Adverse reactionsExact identifier
unii: 0I55128JYK
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
TheophyllineTHEOPHYLLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.701fbf9c-e06b-46f4-863b-981acf3021aa2025-07-10Warnings, Adverse reactionsExact identifier
rxcui: 317769
rxcui: 314241
unii: 0I55128JYK
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
unii: B1QE5P712K
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
TheophyllineTHEOPHYLLINEBryant Ranch Prepack955dba5e-c3b7-4a45-8650-e1b4722dbaea2024-11-20Warnings, Adverse reactionsExact identifier
unii: 0I55128JYK

Reported adverse events (FAERS/openFDA)#

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