Aminophylline

Product NDC
0404-9813
11-digit product format
004049813
Labeler code
0404
Product ID
0404-9813_13bc9538-700e-4405-bf4e-802b1450ca7b
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
Rxcui1724668

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
0404-9813-10Aminophylline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
0404-9813-10Aminophylline1 in 1 BAGINJECTION, SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9813AMINOPHYLLINE INJECTION, SOLUTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20240405_9066bdd0-cb03-40ed-abfa-1b6fb1fff607.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724668aminophylline 250 MG in 10 ML InjectionPSN9066bdd0-cb03-40ed-abfa-1b6fb1fff6075
172466810 ML aminophylline 25 MG/ML InjectionSCD9066bdd0-cb03-40ed-abfa-1b6fb1fff6075
1724668aminophylline (as aminophylline dihydrate) 250 MG per 10 ML InjectionSY9066bdd0-cb03-40ed-abfa-1b6fb1fff6075
1724668aminophylline 250 MG per 10 ML InjectionSY9066bdd0-cb03-40ed-abfa-1b6fb1fff6075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9813-10004049813101 VIAL, SINGLE-DOSE in 1 BAG (0404-9813-10) / 10 mL in 1 VIAL, SINGLE-DOSE2022-01-080000-00-00NoNoCurrent