FDA.reportPublic FDA data

ELIXOPHYLLIN

Product NDC
70408-644
11-digit product format
704080644
Labeler code
70408
Product ID
70408-644_50870177-6eff-41c1-85a4-670836703a30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
THEOPHYLLINE ANHYDROUS
Dosage form
LIQUID
Route
ORAL
Labeler
Nostrum Laboratories, Inc.
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
No
Listing certified through
2020-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70408-644-34ELIXOPHYLLIN473 mL in 1 BOTTLELIQUID4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70408-644-34ML - Milliliter70408-644e004792f-2ad4-4861-a2a5-65b6c5f3279012016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70408-644ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [NOSTRUM LABORATORIES, INC.]2Legacy NDC, 1 package rows20181214_b488f996-2f80-438a-8333-b837f9acd4fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756226Elixophyllin 80 MG in 15 mL ElixirPSN8328cefd-49aa-4621-a7c3-49a14a19cbe74
313306theophylline 80 MG in 15 mL Oral SolutionPSN8328cefd-49aa-4621-a7c3-49a14a19cbe74
756226theophylline 5.33 MG/ML Oral Solution [Elixophyllin]SBD8328cefd-49aa-4621-a7c3-49a14a19cbe74
313306theophylline 5.33 MG/ML Oral SolutionSCD8328cefd-49aa-4621-a7c3-49a14a19cbe74
756226Elixophyllin 100 MG per 18.75 ML ElixirSY8328cefd-49aa-4621-a7c3-49a14a19cbe74
756226Elixophyllin 5.33 MG/ML Oral SolutionSY8328cefd-49aa-4621-a7c3-49a14a19cbe74
756226Elixophyllin 80 MG per 15 ML ElixirSY8328cefd-49aa-4621-a7c3-49a14a19cbe74
313306theophylline 100 MG per 18.75 ML Oral SolutionSY8328cefd-49aa-4621-a7c3-49a14a19cbe74
313306theophylline 80 MG per 15 ML Oral SolutionSY8328cefd-49aa-4621-a7c3-49a14a19cbe74
756226Elixophyllin 80 MG in 15 mL ElixirPSNb488f996-2f80-438a-8333-b837f9acd4fc2
313306theophylline 80 MG in 15 mL Oral SolutionPSNb488f996-2f80-438a-8333-b837f9acd4fc2
756226theophylline 5.33 MG/ML Oral Solution [Elixophyllin]SBDb488f996-2f80-438a-8333-b837f9acd4fc2
313306theophylline 5.33 MG/ML Oral SolutionSCDb488f996-2f80-438a-8333-b837f9acd4fc2
756226Elixophyllin 100 MG per 18.75 ML ElixirSYb488f996-2f80-438a-8333-b837f9acd4fc2
756226Elixophyllin 5.33 MG/ML Oral SolutionSYb488f996-2f80-438a-8333-b837f9acd4fc2
756226Elixophyllin 80 MG per 15 ML ElixirSYb488f996-2f80-438a-8333-b837f9acd4fc2
313306theophylline 100 MG per 18.75 ML Oral SolutionSYb488f996-2f80-438a-8333-b837f9acd4fc2
313306theophylline 80 MG per 15 ML Oral SolutionSYb488f996-2f80-438a-8333-b837f9acd4fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70408-644-3470408064434473 mL in 1 BOTTLE (70408-644-34) 473 ml2009-10-010000-00-00NoNoCurrent