FDA.reportPublic FDA data

DOPAMINE HCI

Product NDC
51662-1220
Requested package NDC
51662-1220-3
11-digit product format
516621220
Labeler code
51662
Product ID
51662-1220_11ffcdfd-1b2f-90a1-e063-6394a90adede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOPAMINE HCI
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
HF Acquisition Co. LLC, DBA Health First
Application
NDA018132
Marketing category
NDA
Marketing start
2018-08-23
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

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N018132-001DOPAMINE HYDROCHLORIDE40MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N018132-002DOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04a50c72e98297…
2026-08-01 22:54:322026-06N018132-003DOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-02-04a50c72e98297…
2026-08-01 22:54:322026-06N018132-004DOPAMINE HYDROCHLORIDE80MG/MLINJECTABLE / INJECTIONAPRLD, RS1982-07-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018132-001AP1a50c72e98297…
2026-08-01 22:54:322026-06N018132-002AP1a50c72e98297…
2026-08-01 22:54:322026-06N018132-003AP1a50c72e98297…
2026-08-01 22:54:322026-06N018132-004AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 51662-1220-3
ndc (product): 51662-1220
ndc11 (package): 51662122003
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

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
74205252-3949-57fa-e053-2991aa0aee4dAvailable 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1220-12020-02-07C16284748780-19d75b9d0-0a4b-f424-e053-dadaa90a57ceDOPAMINE HCI INJ., USP 400mg (40mg/mL) 10mL VIAL
51662-1220-12020-01-31C16284748780-19d75b9d0-0a4b-f424-e053-dadaa90a57ceDOPAMINE HCI INJ., USP 400mg (40mg/mL) 10mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1220-1DOPAMINE HCI10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE107
51662-1220-2DOPAMINE HCI1 in 1 POUCHINJECTION, SOLUTION, CONCENTRATE17
51662-1220-2DOPAMINE HCI10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE107
51662-1220-3DOPAMINE HCI25 in 1 CASEINJECTION, SOLUTION, CONCENTRATE257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1220DOPAMINE HCI INJECTION, SOLUTION, CONCENTRATE [HF ACQUISITION CO. LLC, DBA HEALTH FIRST]7Current NDC, Legacy NDC, 4 package rows20240224_74205252-3949-57fa-e053-2991aa0aee4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743938DOPamine HCl 40 MG/ML in 10 ML InjectionPSN74205252-3949-57fa-e053-2991aa0aee4d7
174393810 ML dopamine hydrochloride 40 MG/ML InjectionSCD74205252-3949-57fa-e053-2991aa0aee4d7
1743938dopamine HCl 40 MG/ML per 10 ML InjectionSY74205252-3949-57fa-e053-2991aa0aee4d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1220-35166212200325 POUCH in 1 CASE (51662-1220-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1220-2) / 10 mL in 1 VIAL, SINGLE-DOSE25 pouch2022-11-100000-00-00NoNoCurrent