Aminophylline

Product NDC
71872-7121
Requested package NDC
71872-7121-1
11-digit product format
718727121
Labeler code
71872
Product ID
71872-7121_9ce56894-7463-c9d5-e053-2a95a90ae63e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aminophylline
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA087242
Marketing category
ANDA
Marketing start
2005-05-10
Marketing end
0000-00-00
Substance
AMINOPHYLLINE DIHYDRATE
Active strength
25 mg/mL
Pharmacologic classes
Methylxanthine [EPC],Xanthines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71872-712171872-7121-1IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087242-001AMINOPHYLLINEAMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRLD, RS1983-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263f01610625f2…
2019-09-15 20:21 UTC2019-09A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087242-001AMINOPHYLLINE25MG/MLINJECTABLE / INJECTIONRS1983-10-26cb3db0bc1861…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71872-7121-12025-01-30C16284748780-12cef2736-846c-d83d-e063-dadaa90ab31f6936595d-255f-0321-e053-2a91aa0a15f7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7121-1Aminophylline10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102
71872-7121-1Aminophylline1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7121AMINOPHYLLINE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Legacy NDC, 2 package rows20200125_6936595d-255f-0321-e053-2a91aa0a15f7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMINOPHYLLINEAMINOPHYLLINEHF Acquisition Co LLC, DBA HealthFirst819207a2-0c37-b275-e053-2a91aa0afb362026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEMedical Purchasing Solutions, LLC52bbc6cd-4baf-7859-e063-6394a90ac87d2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEHospira, Inc.9a663ef3-881f-48bd-2689-3713b24545c22026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEProPharma Distribution3f000254-a9f1-c8c7-e063-6394a90aa33f2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEHenry Schein, Inc.9066bdd0-cb03-40ed-abfa-1b6fb1fff6072025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEHenry Schein, Inc.9a9dedc4-ce04-4b22-9922-81a215ff59ed2025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AMINOPHYLLINEAMINOPHYLLINEHF Acquisition Co LLC, DBA HealthFirst75c2fc3e-28ac-c1b1-e053-2991aa0aee9f2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242
AminophyllineAMINOPHYLLINEMedical Purchasing Solutions, LLC6bca324f-6999-4c16-e053-2a91aa0aee452023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087242
application number: ANDA087242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7121-1718727121011 VIAL, SINGLE-DOSE in 1 BAG (71872-7121-1) > 10 mL in 1 VIAL, SINGLE-DOSE2018-03-300000-00-00NoNoCurrent