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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-5921DDiscontinued by firm2026-08-11
excluded packagepackage0409-59210409-5921-10DDiscontinued by firm2026-08-11

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-5921-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-5921-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-5921-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-5921-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-5921-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-5921-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-5921-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-5921-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-5921-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-5921-10ad56d346431e…cc804d4bbf1e…

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…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C229N9DX94Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1724666Internal RxNorm lookup
1724668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a663ef3-881f-48bd-2689-3713b24545c2Available on FDA.report

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#

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

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
ndc (product): 0409-5921
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 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