AMINOPHYLLINE

Product NDC
51662-1204
11-digit product format
516621204
Labeler code
51662
Product ID
51662-1204_0e739cf0-6ac6-03b2-e063-6294a90a6548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMINOPHYLLINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA087242
Marketing category
ANDA
Marketing start
2018-09-13
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1204-1AMINOPHYLLINE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION108
51662-1204-2AMINOPHYLLINE1 mL in 1 POUCHINJECTION, SOLUTION18
51662-1204-3AMINOPHYLLINE25 in 1 CASEINJECTION, SOLUTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1204AMINOPHYLLINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]8Current NDC, Legacy NDC, 3 package rows20240109_75c2fc3e-28ac-c1b1-e053-2991aa0aee9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1204-15166212040110 mL in 1 VIAL, SINGLE-DOSE (51662-1204-1) 10 ml2018-09-130000-00-00NoNoCurrent
51662-1204-2516621204021 mL in 1 POUCH1 mlHistorical
51662-1204-35166212040325 POUCH in 1 CASE (51662-1204-3) / 1 mL in 1 POUCH (51662-1204-2) 25 pouch2020-06-150000-00-00NoNoCurrent