Application 018132

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION40MG/MLYesYes
002DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/100MLYesYes
003DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION160MG/100MLYesYes
004DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/MLYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018132-001DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N018132-002DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04
N018132-003DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04
N018132-004DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N018132-001AP
N018132-002AP
N018132-003AP
N018132-004AP

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-09d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018132-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018132-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018132-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018132-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018132-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018132-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018132-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018132-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018132-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018132-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018132-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018132-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018132-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018132-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018132-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018132-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018132-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018132-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018132-004AP1d06236e962d9…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOPamine HydrochlorideDOPAMINE HYDROCHLORIDEHospira, Inc.1f306ad2-3606-4525-5a8a-ce78f426c1a22026-05-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
ndc (product): 0409-9104
ndc (product): 0409-5820
DOPamine HydrochlorideDOPAMINE HYDROCHLORIDEProPharma Distribution45b0729e-529b-02f6-e063-6294a90a31d32025-12-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEHenry Schein, Inc.fc1eb709-ce72-413e-9043-8e463ef0fd362025-10-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
ndc (product): 0404-9981
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEHenry Schein, Inc.460906f7-b532-4ddb-a799-ad7b504881432025-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
ndc (product): 0404-9982
DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health First74205252-3949-57fa-e053-2991aa0aee4d2024-02-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
ndc (product): 51662-1220
DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirst763d2b07-9cea-782e-e053-2a91aa0adc012024-02-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
ndc (product): 51662-1291
DOPamine HydrochlorideDOPAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCb61fffd0-7bc8-09e2-e053-2995a90ae0e42023-05-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
ndc (product): 71872-7066

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9981Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9981Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9981Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9982Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9982Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0409-5820DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-5820DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-5820DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-9104DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-9104DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-9104DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
55154-4735DOPamine HydrochlorideDopamine HydrochlorideCardinal HealthNDACurrent
71872-7066DOPamine HydrochlorideDopamine HydrochlorideMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75411SUPPL 2023-09-13
75407SUPPL 2023-09-12
849SUPPL2014-05-19
33439SUPPL2014-05-15