FDA.reportPublic FDA data

Aminophylline

Product NDC
0409-5922
11-digit product format
004095922
Labeler code
0409
Product ID
0409-5922_a36bc745-4366-4883-8e7d-4df241a069c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminophylline
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA087242
Marketing category
ANDA
Marketing start
2005-02-28
Substance
AMINOPHYLLINE DIHYDRATE
Active strength
25 mg/mL
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
Aminophylline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMINOPHYLLINE DIHYDRATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC229N9DX94
Rxcui1724666, 1724668

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
0409-5922-01Aminophylline25 in 1 TRAYINJECTION, SOLUTION2529
0409-5922-16Aminophylline20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-5922-01ML - Milliliter0409-59226f4eb268-c0db-46fc-b949-f98c51664d0112012-07-24
0409-5922-16ML - Milliliter0409-5922396425b3-63ba-43c7-8be7-56221f37968512019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMINOPHYLLINE DIHYDRATEACTIVE INGREDIENTC229N9DX94AMINOPHYLLINE (AMINOPHYLLINE DIHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKAMINOPHYLLINE (AMINOPHYLLINE DIHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
ETHYLENEDIAMINEINACTIVE INGREDIENT60V9STC53FAMINOPHYLLINE (AMINOPHYLLINE DIHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RAMINOPHYLLINE (AMINOPHYLLINE DIHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-5922AMINOPHYLLINE INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 2 package rows20241018_9a663ef3-881f-48bd-2689-3713b24545c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724668aminophylline 250 MG in 10 ML InjectionPSN9a663ef3-881f-48bd-2689-3713b24545c229
1724666aminophylline 500 MG in 20 ML InjectionPSN9a663ef3-881f-48bd-2689-3713b24545c229
172466810 ML aminophylline 25 MG/ML InjectionSCD9a663ef3-881f-48bd-2689-3713b24545c229
172466620 ML aminophylline 25 MG/ML InjectionSCD9a663ef3-881f-48bd-2689-3713b24545c229
1724668aminophylline (as aminophylline dihydrate) 250 MG per 10 ML InjectionSY9a663ef3-881f-48bd-2689-3713b24545c229
1724666aminophylline (as aminophylline dihydrate) 500 MG per 20 ML InjectionSY9a663ef3-881f-48bd-2689-3713b24545c229
1724668aminophylline 250 MG per 10 ML InjectionSY9a663ef3-881f-48bd-2689-3713b24545c229
1724666aminophylline 500 MG per 20 ML InjectionSY9a663ef3-881f-48bd-2689-3713b24545c229
1724666aminophylline 500 MG in 20 ML InjectionPSN9a9dedc4-ce04-4b22-9922-81a215ff59ed7
1724666aminophylline 500 MG in 20 ML InjectionPSN819207a2-0c37-b275-e053-2a91aa0afb367
172466620 ML aminophylline 25 MG/ML InjectionSCD9a9dedc4-ce04-4b22-9922-81a215ff59ed7
172466620 ML aminophylline 25 MG/ML InjectionSCD819207a2-0c37-b275-e053-2a91aa0afb367
1724666aminophylline (as aminophylline dihydrate) 500 MG per 20 ML InjectionSY819207a2-0c37-b275-e053-2a91aa0afb367
1724666aminophylline (as aminophylline dihydrate) 500 MG per 20 ML InjectionSY9a9dedc4-ce04-4b22-9922-81a215ff59ed7
1724666aminophylline 500 MG per 20 ML InjectionSY819207a2-0c37-b275-e053-2a91aa0afb367
1724666aminophylline 500 MG per 20 ML InjectionSY9a9dedc4-ce04-4b22-9922-81a215ff59ed7
1724666aminophylline 500 MG in 20 ML InjectionPSN6bca324f-6999-4c16-e053-2a91aa0aee453
172466620 ML aminophylline 25 MG/ML InjectionSCD6bca324f-6999-4c16-e053-2a91aa0aee453
1724666aminophylline (as aminophylline dihydrate) 500 MG per 20 ML InjectionSY6bca324f-6999-4c16-e053-2a91aa0aee453
1724666aminophylline 500 MG per 20 ML InjectionSY6bca324f-6999-4c16-e053-2a91aa0aee453
1724666aminophylline 500 MG in 20 ML InjectionPSN3f000254-a9f1-c8c7-e063-6394a90aa33f2
172466620 ML aminophylline 25 MG/ML InjectionSCD3f000254-a9f1-c8c7-e063-6394a90aa33f2
1724666aminophylline (as aminophylline dihydrate) 500 MG per 20 ML InjectionSY3f000254-a9f1-c8c7-e063-6394a90aa33f2
1724666aminophylline 500 MG per 20 ML InjectionSY3f000254-a9f1-c8c7-e063-6394a90aa33f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-5922-010040959220125 VIAL, SINGLE-DOSE in 1 TRAY (0409-5922-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-5922-16) 2005-02-280000-00-00NoNoCurrent
0409-5922-160040959221620 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical