FDA.reportPublic FDA data

ELIXOPHYLLIN

Product NDC
17856-0644
11-digit product format
178560644
Labeler code
17856
Product ID
17856-0644_a2be0daf-8d5e-469f-a61b-cfcee7a19c16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
THEOPHYLLINE ANHYDROUS
Dosage form
LIQUID
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA085186
Marketing category
ANDA
Marketing start
2009-10-01
Marketing end
0000-00-00
Substance
THEOPHYLLINE ANHYDROUS
Active strength
80 mg/15mL
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0644-12020-01-31C16284748780-19d75b9d0-6b59-f424-e053-dadaa90a57ceRx Only
17856-0644-22020-01-31C16284748780-19d75b9d0-6b59-f424-e053-dadaa90a57ceRx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0644-1ELIXOPHYLLIN15 mL in 1 CUPLIQUID155
17856-0644-2ELIXOPHYLLIN18.75 mL in 1 CUPLIQUID18.755

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0644-1ML - Milliliter17856-06442a5b8b7e-2d2b-48c6-b29b-274752b8f0cf12013-02-13
17856-0644-2ML - Milliliter17856-064459a65304-cd8f-4c20-bb87-f3f29e46244112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5
WATERINACTIVE INGREDIENT059QF0KO0RELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0644ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS]5Legacy NDC, 2 package rows20120510_7a5a367f-8461-4b15-99fc-f89aa7d5936e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756226Elixophyllin 80 MG in 15 mL ElixirPSN7a5a367f-8461-4b15-99fc-f89aa7d5936e5
313306theophylline 80 MG in 15 mL Oral SolutionPSN7a5a367f-8461-4b15-99fc-f89aa7d5936e5
756226theophylline 5.33 MG/ML Oral Solution [Elixophyllin]SBD7a5a367f-8461-4b15-99fc-f89aa7d5936e5
313306theophylline 5.33 MG/ML Oral SolutionSCD7a5a367f-8461-4b15-99fc-f89aa7d5936e5
756226Elixophyllin 100 MG per 18.75 ML ElixirSY7a5a367f-8461-4b15-99fc-f89aa7d5936e5
756226Elixophyllin 5.33 MG/ML Oral SolutionSY7a5a367f-8461-4b15-99fc-f89aa7d5936e5
756226Elixophyllin 80 MG per 15 ML ElixirSY7a5a367f-8461-4b15-99fc-f89aa7d5936e5
313306theophylline 100 MG per 18.75 ML Oral SolutionSY7a5a367f-8461-4b15-99fc-f89aa7d5936e5
313306theophylline 80 MG per 15 ML Oral SolutionSY7a5a367f-8461-4b15-99fc-f89aa7d5936e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0644-11785606440115 mL in 1 CUP15 mlHistorical
17856-0644-21785606440218.75 mL in 1 CUP18.75 mlHistorical