FDA.reportPublic FDA data

Aminophylline

Product NDC
0409-5921
11-digit product format
004095921
Labeler code
0409
Product ID
0409-5921_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
2005-05-10
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
0409-5921-01Aminophylline25 in 1 TRAYINJECTION, SOLUTION2529
0409-5921-16Aminophylline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-5921-01ML - Milliliter0409-5921e3958f58-f9a4-42eb-a8c3-f1b75a9df8ac12012-07-24
0409-5921-09ML - Milliliter0409-5921bef31716-3249-40f2-b619-28cdfa12108112016-11-08
0409-5921-10ML - Milliliter0409-5921c5add6ab-ea4c-4beb-a517-b9d49692f09b12015-10-02
0409-5921-16ML - Milliliter0409-5921f7c8790d-85db-435d-8cb8-d4a5f29852f812019-08-06

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
0409-5921AMINOPHYLLINE 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
1724668aminophylline 250 MG in 10 ML InjectionPSN75c2fc3e-28ac-c1b1-e053-2991aa0aee9f8
172466810 ML aminophylline 25 MG/ML InjectionSCD75c2fc3e-28ac-c1b1-e053-2991aa0aee9f8
1724668aminophylline (as aminophylline dihydrate) 250 MG per 10 ML InjectionSY75c2fc3e-28ac-c1b1-e053-2991aa0aee9f8
1724668aminophylline 250 MG per 10 ML InjectionSY75c2fc3e-28ac-c1b1-e053-2991aa0aee9f8
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
1724668aminophylline 250 MG in 10 ML InjectionPSN6936595d-255f-0321-e053-2a91aa0a15f72
172466810 ML aminophylline 25 MG/ML InjectionSCD6936595d-255f-0321-e053-2a91aa0a15f72
1724668aminophylline (as aminophylline dihydrate) 250 MG per 10 ML InjectionSY6936595d-255f-0321-e053-2a91aa0a15f72
1724668aminophylline 250 MG per 10 ML InjectionSY6936595d-255f-0321-e053-2a91aa0a15f72
1724668aminophylline 250 MG in 10 ML InjectionPSN52bbc6cd-4baf-7859-e063-6394a90ac87d1
172466810 ML aminophylline 25 MG/ML InjectionSCD52bbc6cd-4baf-7859-e063-6394a90ac87d1
1724668aminophylline (as aminophylline dihydrate) 250 MG per 10 ML InjectionSY52bbc6cd-4baf-7859-e063-6394a90ac87d1
1724668aminophylline 250 MG per 10 ML InjectionSY52bbc6cd-4baf-7859-e063-6394a90ac87d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-5921-010040959210125 VIAL, SINGLE-DOSE in 1 TRAY (0409-5921-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-5921-16) 2005-05-100000-00-00NoNoCurrent
0409-5921-160040959211610 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical