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 4 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
THEOPHYLLINETHEOPHYLLINELeading Pharma, LLCac490ebf-24e1-47c4-a932-ad4dcafe7aad2024-10-07Warnings, Adverse reactionsExact identifier
rxcui: 317769
rxcui: 314241
TheophyllineTHEOPHYLLINECranbury Pharmaceuticals, LLC78a99bfe-6ebe-4ace-80b0-ee019921435e2024-08-30Warnings, Adverse reactionsExact identifier
unii: 0I55128JYK
Theo-24THEOPHYLLINE ANHYDROUSENDO USA, Inc.7a108fa0-c230-475f-be93-6f864b98a4102024-07-08Warnings, Adverse reactionsExact identifier
unii: 0I55128JYK
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
TheophyllineTHEOPHYLLINEViona Pharmaceuticals Incabdfb9b9-9402-4761-9347-8eb1c4d862422024-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA218063
rxcui: 317769
rxcui: 314241
unii: 0I55128JYK
TheophyllineTHEOPHYLLINEZydus Lifesciences Limited7339f98d-b996-4e20-a7a7-315fd2a9fa4d2024-05-22Exact identifier
application number: ANDA218063
ndc (package): 70771-1782-1
ndc (package): 70771-1783-1
ndc (product): 70771-1783
ndc (product): 70771-1782
ndc11 (package): 70771178301
rxcui: 317769
rxcui: 314241
spl id: 86fdabb8-c881-4695-8127-59b26998e365
spl set id: 7339f98d-b996-4e20-a7a7-315fd2a9fa4d
unii: 0I55128JYK
TheophyllineTHEOPHYLLINEHarman Finochem Limited098db8bb-fa9a-4577-b7d9-86caaefc168a2024-04-27Warnings, Adverse reactionsExact identifier
rxcui: 317769
rxcui: 314241
unii: 0I55128JYK
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
unii: FZ989GH94E
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
unii: FZ989GH94E
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: FZ989GH94E
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
unii: FZ989GH94E
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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