DOPAMINE HYDROCHLORIDE

Product NDC
51662-1316
11-digit product format
516621316
Labeler code
51662
Product ID
51662-1316_101df49b-fde7-ec91-e063-6294a90a8a90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOPAMINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA018826
Marketing category
NDA
Marketing start
2018-10-19
Substance
DOPAMINE HYDROCHLORIDE
Active strength
1.6 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 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…

Additional Listing Data#

Finished product
Yes
Brand name base
DOPAMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE1.6 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1743877Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7896052c-2a72-ca89-e053-2a91aa0ae86eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762Product name220180613
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
b2a69ae1-a082-5ec0-42b6-e3c38800f173Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1316-1DOPAMINE HYDROCHLORIDE250 mL in 1 BAGINJECTION, SOLUTION2506
51662-1316-2DOPAMINE HYDROCHLORIDE250 mL in 1 BAGINJECTION, SOLUTION2506
51662-1316-2DOPAMINE HYDROCHLORIDE1 in 1 POUCHINJECTION, SOLUTION16
51662-1316-3DOPAMINE HYDROCHLORIDE12 in 1 CASEINJECTION, SOLUTION126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1316DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]6Current NDC, Legacy NDC, 4 package rows20240131_7896052c-2a72-ca89-e053-2a91aa0ae86e.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 · 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743877DOPamine HCl 1600 MCG/ML in 250 ML InjectionPSN7896052c-2a72-ca89-e053-2a91aa0ae86e6
1743877250 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD7896052c-2a72-ca89-e053-2a91aa0ae86e6
1743877dopamine HCl 1600 MCG/ML per 250 ML InjectionSY7896052c-2a72-ca89-e053-2a91aa0ae86e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1316-151662131601250 mL in 1 BAG (51662-1316-1) 250 ml2018-10-190000-00-00NoNoCurrent
51662-1316-251662131602250 mL in 1 BAG250 mlHistorical
51662-1316-35166213160312 POUCH in 1 CASE (51662-1316-3) / 1 BAG in 1 POUCH (51662-1316-2) / 250 mL in 1 BAG12 pouch2022-09-120000-00-00NoNoCurrent