DOPamine Hydrochloride

Product NDC
0409-5820
11-digit product format
004095820
Labeler code
0409
Product ID
0409-5820_7a125e39-1ecb-4c76-931a-efc9b5921d1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dopamine Hydrochloride
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018132
Marketing category
NDA
Marketing start
2005-08-25
Substance
DOPAMINE HYDROCHLORIDE
Active strength
40 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
DOPamine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7L3E358N9LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1743938Internal RxNorm lookup
1743941Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f306ad2-3606-4525-5a8a-ce78f426c1a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762Product name220180613
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
b2a69ae1-a082-5ec0-42b6-e3c38800f173Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-5820-01DOPamine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE2522
0409-5820-11DOPamine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-5820-01ML - Milliliter0409-5820d41f7382-b0c5-4d6a-bcf2-c25b33407f2712012-07-24
0409-5820-11ML - Milliliter0409-58203a945313-9e87-4ff5-8e66-ba2d81bd6add12019-08-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-5820DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]21Current NDC, Legacy NDC, 2 package rows20241105_1f306ad2-3606-4525-5a8a-ce78f426c1a2.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 · 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): 0409-5820
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
Dopamine HydrochlorideDOPAMINE HYDROCHLORIDEHenry Schein, Inc.460906f7-b532-4ddb-a799-ad7b504881432025-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
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
DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirst763d2b07-9cea-782e-e053-2a91aa0adc012024-02-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132
DOPamine HydrochlorideDOPAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCb61fffd0-7bc8-09e2-e053-2995a90ae0e42023-05-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018132
application number: NDA018132

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743938DOPamine HCl 40 MG/ML in 10 ML InjectionPSN1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743941DOPamine HCl 40 MG/ML in 5 ML InjectionPSN1f306ad2-3606-4525-5a8a-ce78f426c1a222
174393810 ML dopamine hydrochloride 40 MG/ML InjectionSCD1f306ad2-3606-4525-5a8a-ce78f426c1a222
17439415 ML dopamine hydrochloride 40 MG/ML InjectionSCD1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743938dopamine HCl 40 MG/ML per 10 ML InjectionSY1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743941dopamine HCl 40 MG/ML per 5 ML InjectionSY1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743941DOPamine HCl 40 MG/ML in 5 ML InjectionPSN460906f7-b532-4ddb-a799-ad7b504881436
17439415 ML dopamine hydrochloride 40 MG/ML InjectionSCD460906f7-b532-4ddb-a799-ad7b504881436
1743941dopamine HCl 40 MG/ML per 5 ML InjectionSY460906f7-b532-4ddb-a799-ad7b504881436
1743941DOPamine HCl 40 MG/ML in 5 ML InjectionPSNb61fffd0-7bc8-09e2-e053-2995a90ae0e42
17439415 ML dopamine hydrochloride 40 MG/ML InjectionSCDb61fffd0-7bc8-09e2-e053-2995a90ae0e42
1743941dopamine HCl 40 MG/ML per 5 ML InjectionSYb61fffd0-7bc8-09e2-e053-2995a90ae0e42
1743941DOPamine HCl 40 MG/ML in 5 ML InjectionPSN45b0729e-529b-02f6-e063-6294a90a31d31
17439415 ML dopamine hydrochloride 40 MG/ML InjectionSCD45b0729e-529b-02f6-e063-6294a90a31d31
1743941dopamine HCl 40 MG/ML per 5 ML InjectionSY45b0729e-529b-02f6-e063-6294a90a31d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-5820-010040958200125 VIAL, SINGLE-DOSE in 1 TRAY (0409-5820-01) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-5820-11) 2005-08-250000-00-00NoNoCurrent
0409-5820-11004095820115 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical