Application 018826

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/100MLYesYes
002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION160MG/100MLYesYes
003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION320MG/100MLYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30
N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30
N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N018826-001AP
N018826-002AP
N018826-003AP

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018826-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018826-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018826-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1983-09-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018826-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018826-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018826-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018826-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018826-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018826-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018826-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018826-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018826-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018826-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018826-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018826-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018826-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018826-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018826-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018826-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018826-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018826-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018826-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018826-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018826-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018826-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018826-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018826-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018826-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018826-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018826-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018826-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018826-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018826-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018826-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018826-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018826-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018826-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018826-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018826-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018826-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018826-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018826-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018826-001AP18072bd15b7f6…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dopamine Hydrochloride in DextroseDOPAMINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.08f23f6e-150d-45ea-098e-f2edf64c21a12026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 018826
application number: NDA018826
ndc (product): 0409-7810
ndc (product): 0409-7809
dopamine hydrochloride in dextroseDOPAMINE HYDROCHLORIDE IN DEXTROSEHF Acquisition Co LLC, DBA HealthFirst513f7cfb-091a-f8c0-e063-6394a90a0fe22026-05-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 018826
application number: NDA018826
DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst7896052c-2a72-ca89-e053-2a91aa0ae86e2024-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 018826
application number: NDA018826
ndc (product): 51662-1316
DOPAMINE HCI IN 5% DEXTROSEDOPAMINE HCI IN 5% DEXTROSEHF Acquisition Co LLC, DBA HealthFirst9989b253-dcf5-7318-e053-2995a90a28902024-01-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 018826
application number: NDA018826
ndc (product): 51662-1458

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1458DOPAMINE HCI IN 5% DEXTROSEDOPAMINE HCI IN 5% DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1458DOPAMINE HCI IN 5% DEXTROSEDOPAMINE HCI IN 5% DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82471SUPPL 2025-06-06
82468SUPPL 2025-06-05
67414SUPPL2021-05-05
67389SUPPL2021-05-04
1097SUPPL2014-05-19
33614SUPPL2014-05-15
40827SUPPL2003-07-28
16061SUPPL2003-04-03