FDA.reportPublic FDA data

Metoclopramide

Product NDC
0409-3414
11-digit product format
004093414
Labeler code
0409
Product ID
0409-3414_d913cdad-c1da-40b5-b72f-4e6a143971e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoclopramide
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA073118
Marketing category
ANDA
Marketing start
2006-02-02
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui311670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86441fd8-22b8-41db-bb26-c70dffc3923bProduct name120210111
340a6817-217a-4b71-9e83-8e2e60c4b0c5Product name120150319
1f2c49ec-0a44-8021-ecde-b27ece080b13Product name120140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3414-01Metoclopramide25 in 1 TRAYINJECTION, SOLUTION2529
0409-3414-11Metoclopramide25 in 1 TRAYINJECTION, SOLUTION2529
0409-3414-18Metoclopramide2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION229
0409-3414-21Metoclopramide2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION229

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3414-01ML - Milliliter0409-341431593d3f-1239-426f-804c-ca049c9ae15c12012-07-24
0409-3414-11ML - Milliliter0409-341429b63c24-42d5-4493-955d-89d9863dce1e12024-09-09
0409-3414-18ML - Milliliter0409-3414b6038368-06bd-4ae2-8648-37371e387a4212016-10-06
0409-3414-21ML - Milliliter0409-34144ab6171c-8f2c-48c8-8e67-a9b606ed43cd12024-09-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE INJECTION, SOLUTION [HOSPIRA, INC.]14
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE INJECTION, SOLUTION [HOSPIRA, INC.]14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMETOCLOPRAMIDE INJECTION, SOLUTION [HOSPIRA, INC.]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETOCLOPRAMIDE INJECTION, SOLUTION [HOSPIRA, INC.]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETOCLOPRAMIDE INJECTION, SOLUTION [HOSPIRA, INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RMETOCLOPRAMIDE INJECTION, SOLUTION [HOSPIRA, INC.]14
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]6
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMETOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]6
WATERINACTIVE INGREDIENT059QF0KO0RMETOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [CARDINAL HEALTH]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3414METOCLOPRAMIDE INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 4 package rows20250122_373ba08b-33ad-49fc-28a7-928e89a65314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311670metoclopramide 10 MG in 2 ML InjectionPSN373ba08b-33ad-49fc-28a7-928e89a6531429
3116702 ML metoclopramide 5 MG/ML InjectionSCD373ba08b-33ad-49fc-28a7-928e89a6531429
311670metoclopramide 10 MG per 2 ML InjectionSY373ba08b-33ad-49fc-28a7-928e89a6531429
311670metoclopramide 10 MG in 2 ML InjectionPSN917494a9-cff1-4ee6-9523-e112120373c518
3116702 ML metoclopramide 5 MG/ML InjectionSCD917494a9-cff1-4ee6-9523-e112120373c518
311670metoclopramide 10 MG per 2 ML InjectionSY917494a9-cff1-4ee6-9523-e112120373c518
311670metoclopramide 10 MG in 2 ML InjectionPSN7678bcd5-1071-0a9b-e053-2a91aa0a38538
3116702 ML metoclopramide 5 MG/ML InjectionSCD7678bcd5-1071-0a9b-e053-2a91aa0a38538
311670metoclopramide 10 MG per 2 ML InjectionSY7678bcd5-1071-0a9b-e053-2a91aa0a38538
311670metoclopramide 10 MG in 2 ML InjectionPSN79754097-4514-297e-e053-2991aa0a48043
3116702 ML metoclopramide 5 MG/ML InjectionSCD79754097-4514-297e-e053-2991aa0a48043
311670metoclopramide 10 MG per 2 ML InjectionSY79754097-4514-297e-e053-2991aa0a48043
311670metoclopramide 10 MG in 2 ML InjectionPSN4046830f-4b87-5e6e-e063-6394a90aeeb82
3116702 ML metoclopramide 5 MG/ML InjectionSCD4046830f-4b87-5e6e-e063-6394a90aeeb82
311670metoclopramide 10 MG per 2 ML InjectionSY4046830f-4b87-5e6e-e063-6394a90aeeb82
311670metoclopramide 10 MG in 2 ML InjectionPSN55b3fecb-f60c-474b-9530-915b0e68bf851
311670metoclopramide 10 MG in 2 ML InjectionPSN41d9ee49-d434-5f9f-e063-6294a90afe0b1
311670metoclopramide 10 MG in 2 ML InjectionPSN3f2b17ea-c265-0cd4-e063-6294a90a9d881
3116702 ML metoclopramide 5 MG/ML InjectionSCD55b3fecb-f60c-474b-9530-915b0e68bf851
3116702 ML metoclopramide 5 MG/ML InjectionSCD41d9ee49-d434-5f9f-e063-6294a90afe0b1
3116702 ML metoclopramide 5 MG/ML InjectionSCD3f2b17ea-c265-0cd4-e063-6294a90a9d881
311670metoclopramide 10 MG per 2 ML InjectionSY55b3fecb-f60c-474b-9530-915b0e68bf851
311670metoclopramide 10 MG per 2 ML InjectionSY41d9ee49-d434-5f9f-e063-6294a90afe0b1
311670metoclopramide 10 MG per 2 ML InjectionSY3f2b17ea-c265-0cd4-e063-6294a90a9d881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3414-010040934140125 VIAL, SINGLE-DOSE in 1 TRAY (0409-3414-01) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-3414-18) 2006-02-020000-00-00NoNoCurrent
0409-3414-110040934141125 VIAL, SINGLE-DOSE in 1 TRAY (0409-3414-11) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3414-21) 2024-08-26NoNoCurrent
0409-3414-18004093414182 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0409-3414-21004093414212 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical