FDA.reportPublic FDA data

Theophylline

Product NDC
62135-556
11-digit product format
621350556
Labeler code
62135
Product ID
62135-556_4a2adbbe-acaa-a2bf-e063-6294a90a44c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA091156
Marketing category
ANDA
Marketing start
2011-04-13
Substance
THEOPHYLLINE ANHYDROUS
Active strength
80 mg/15mL
Pharmacologic classes
Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theophylline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0I55128JYK
Rxcui313306

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-556-24Theophylline2 in 1 BOXSOLUTION24
62135-556-24Theophylline10 in 1 TRAYSOLUTION104
62135-556-47Theophylline473 mL in 1 BOTTLESOLUTION4734
62135-556-51Theophylline15 mL in 1 CUPSOLUTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-556-24ML - Milliliter62135-55687ba9ed5-4785-471c-8255-30364b6fda8912024-09-09
62135-556-47ML - Milliliter62135-55653e20bca-da93-4f86-a35a-db038f8b947f12022-12-07
62135-556-51ML - Milliliter62135-5569131ca28-69c8-459e-8115-ce7c6835c11f12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-556THEOPHYLLINE SOLUTION [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 4 package rows20240602_1b685384-5d96-46fa-b93b-e96538a2cfe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313306theophylline 80 MG in 15 mL Oral SolutionPSN1b685384-5d96-46fa-b93b-e96538a2cfe74
313306theophylline 5.33 MG/ML Oral SolutionSCD1b685384-5d96-46fa-b93b-e96538a2cfe74
313306theophylline 100 MG per 18.75 ML Oral SolutionSY1b685384-5d96-46fa-b93b-e96538a2cfe74
313306theophylline 80 MG per 15 ML Oral SolutionSY1b685384-5d96-46fa-b93b-e96538a2cfe74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-556-24621350556242 TRAY in 1 BOX (62135-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-556-51) 2 tray2024-05-31NoNoCurrent
62135-556-4762135055647473 mL in 1 BOTTLE (62135-556-47) 473 ml2022-10-270000-00-00NoNoCurrent
62135-556-516213505565115 mL in 1 CUP15 mlHistorical