FDA.reportPublic FDA data

THEOPHYLLINE

Product NDC
0121-0820
11-digit product format
001210820
Labeler code
0121
Product ID
0121-0820_895f63e5-665b-4227-8e44-6971ba5ce294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
THEOPHYLLINE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA206344
Marketing category
ANDA
Marketing start
2016-12-16
Substance
THEOPHYLLINE
Active strength
80 mg/15mL
Pharmacologic classes
Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
THEOPHYLLINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE80 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC137DTR5RG
Rxcui313306

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0820-04THEOPHYLLINE118 mL in 1 BOTTLESOLUTION1189
0121-0820-16THEOPHYLLINE473 mL in 1 BOTTLESOLUTION4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0820-16ML - Milliliter0121-0820f944f03e-35f9-4f45-8b91-a3f410069f1612017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0820THEOPHYLLINE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]9Current NDC, Legacy NDC, 2 package rows20241121_32b9780f-c46f-4e0f-9641-2cab60600e6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313306theophylline 80 MG in 15 mL Oral SolutionPSN32b9780f-c46f-4e0f-9641-2cab60600e6e9
313306theophylline 5.33 MG/ML Oral SolutionSCD32b9780f-c46f-4e0f-9641-2cab60600e6e9
313306theophylline 100 MG per 18.75 ML Oral SolutionSY32b9780f-c46f-4e0f-9641-2cab60600e6e9
313306theophylline 80 MG per 15 ML Oral SolutionSY32b9780f-c46f-4e0f-9641-2cab60600e6e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0820-0400121082004118 mL in 1 BOTTLE (0121-0820-04) 118 ml2016-12-160000-00-00NoNoCurrent
0121-0820-1600121082016473 mL in 1 BOTTLE (0121-0820-16) 473 ml2016-12-160000-00-00NoNoCurrent