DOPAMINE HCI

Product NDC
51662-1291
11-digit product format
516621291
Labeler code
51662
Product ID
51662-1291_1200755c-a6f2-f1b4-e063-6394a90aaf1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOPAMINE HCI
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA018132
Marketing category
NDA
Marketing start
2018-09-19
Substance
DOPAMINE HYDROCHLORIDE
Active strength
40 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct51662-1291YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51662-129151662-1291-1YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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 HCI
Listing expiration
2026-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
763d2b07-9cea-782e-e053-2a91aa0adc01Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762Product name220180613
b2a69ae1-a082-5ec0-42b6-e3c38800f173Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1291-1DOPAMINE HCI5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE57
51662-1291-2DOPAMINE HCI1 in 1 POUCHINJECTION, SOLUTION, CONCENTRATE17
51662-1291-2DOPAMINE HCI5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE57
51662-1291-3DOPAMINE HCI25 in 1 CASEINJECTION, SOLUTION, CONCENTRATE257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1291DOPAMINE HCI INJECTION, SOLUTION, CONCENTRATE [HF ACQUISITION CO LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 4 package rows20240224_763d2b07-9cea-782e-e053-2a91aa0adc01.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
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1291-1516621291015 mL in 1 VIAL, SINGLE-DOSE (51662-1291-1) 5 ml2018-09-190000-00-00NoNoCurrent
51662-1291-2516621291021 in 1 POUCHHistorical
51662-1291-35166212910325 POUCH in 1 CASE (51662-1291-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1291-2) / 5 mL in 1 VIAL, SINGLE-DOSE25 pouch2022-09-150000-00-00NoNoCurrent