FDA.reportPublic FDA data

NDC 0472-1444-28 - 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
0472-1444
Requested NDC
0472-1444-28
Package NDCs from labels
0472-1444-16, 0472-1444-28
Manufacturer
Actavis Mid Atlantic LLC
Effective date
2007-04-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Theophylline - Actavis Mid Atlantic LLCActavis Mid Atlantic LLC2007-04-17HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-1444-16Theophylline473 mL in 1 BOTTLELIQUID4731
0472-1444-28Theophylline3785 mL in 1 BOTTLELIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-1444THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]12 package rows20070426_A918AE8C-6485-42D2-AEBA-3785197C3D7B.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
theophylline, anhydrousACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
theophylline, anhydrousACTIVE MOIETY0I55128JYKTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
alcoholINACTIVE INGREDIENT3K9958V90MTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
artificial mixed fruit flavorINACTIVE INGREDIENTTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
citric acidINACTIVE INGREDIENT2968PHW8QPTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
fd&c red#40INACTIVE INGREDIENTTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3THEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
saccharin sodiumINACTIVE INGREDIENTTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1
waterINACTIVE INGREDIENT059QF0KO0RTHEOPHYLLINE (THEOPHYLLINE, ANHYDROUS) LIQUID [ACTAVIS MID ATLANTIC LLC]1

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 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheophyllineTHEOPHYLLINEChartwell RX, LLC1b685384-5d96-46fa-b93b-e96538a2cfe72026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 313306
TheophyllineTHEOPHYLLINEATLANTIC BIOLOGICALS CORP.47e484c2-f59e-4a71-bb97-c90f128ac3452025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 313306
TheophyllineTHEOPHYLLINEChartwell Governmental & Specialty RX, LLC.e2716dac-8b23-4e06-bc3e-4dd76b7c813e2025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 313306
TheophyllineTHEOPHYLLINEBryant Ranch Prepack62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd2025-10-22Warnings, Adverse reactionsExact identifier
rxcui: 313306
TheophyllineTHEOPHYLLINEBryant Ranch Prepack955dba5e-c3b7-4a45-8650-e1b4722dbaea2024-11-20Warnings, Adverse reactionsExact identifier
rxcui: 313306
THEOPHYLLINETHEOPHYLLINEPAI Holdings, LLC dba PAI Pharma32b9780f-c46f-4e0f-9641-2cab60600e6e2024-11-19Warnings, Adverse reactionsExact identifier
rxcui: 313306
TheophyllineTHEOPHYLLINECranbury Pharmaceuticals, LLC78a99bfe-6ebe-4ace-80b0-ee019921435e2024-08-30Warnings, Adverse reactionsExact identifier
rxcui: 313306
A9A0E6CE-C1B4-A763-0CCD-DC7B8C2AAC3AA918AE8C-6485-42D2-AEBA-3785197C3D7B2007-04-17Warnings, Adverse reactionsExact identifier
spl id: A9A0E6CE-C1B4-A763-0CCD-DC7B8C2AAC3A
spl set id: A918AE8C-6485-42D2-AEBA-3785197C3D7B

Reported adverse events (FAERS/openFDA)#

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