Aminophylline

Product NDC
0404-9814
11-digit product format
004049814
Labeler code
0404
Product ID
0404-9814_5cb03b55-9ea0-43ef-88a8-502607c20bd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminophylline
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA087242
Marketing category
ANDA
Marketing start
2022-01-08
Substance
AMINOPHYLLINE DIHYDRATE
Active strength
25 mg/mL
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
Aminophylline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOPHYLLINE DIHYDRATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC229N9DX94
Rxcui1724666

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
0404-9814-20Aminophylline1 in 1 BAGINJECTION, SOLUTION17
0404-9814-20Aminophylline20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9814AMINOPHYLLINE INJECTION, SOLUTION [HENRY SCHEIN, INC.]6Current NDC, Legacy NDC, 2 package rows20240514_9a9dedc4-ce04-4b22-9922-81a215ff59ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724666aminophylline 500 MG in 20 ML InjectionPSN9a9dedc4-ce04-4b22-9922-81a215ff59ed7
172466620 ML aminophylline 25 MG/ML InjectionSCD9a9dedc4-ce04-4b22-9922-81a215ff59ed7
1724666aminophylline (as aminophylline dihydrate) 500 MG per 20 ML InjectionSY9a9dedc4-ce04-4b22-9922-81a215ff59ed7
1724666aminophylline 500 MG per 20 ML InjectionSY9a9dedc4-ce04-4b22-9922-81a215ff59ed7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9814-20004049814201 VIAL, SINGLE-DOSE in 1 BAG (0404-9814-20) / 20 mL in 1 VIAL, SINGLE-DOSE2022-01-080000-00-00NoNoCurrent