Metoclopramide

Product NDC
55154-2353
11-digit product format
551542353
Labeler code
55154
Product ID
55154-2353_39d89336-310c-42dc-8242-23637acfcda4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOCLOPRAMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA073118
Marketing category
ANDA
Marketing start
2009-09-22
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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073118-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A073118-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-173f01610625f2…
2019-09-15 20:21 UTC2019-09A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073118-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS1991-01-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073118-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073118-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073118-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073118-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073118-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073118-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073118-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073118-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073118-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073118-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073118-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073118-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073118-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073118-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073118-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073118-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073118-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073118-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073118-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073118-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073118-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A073118-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073118-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073118-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073118-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A073118-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073118-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073118-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073118-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073118-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073118-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073118-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073118-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073118-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A073118-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A073118-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073118-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073118-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073118-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073118-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W1792A2RVDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311670Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
917494a9-cff1-4ee6-9523-e112120373c5Available on FDA.report

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
55154-2353-5Metoclopramide2 mL in 1 VIALINJECTION, SOLUTION218
55154-2353-5Metoclopramide5 in 1 BAGINJECTION, SOLUTION518

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2353METOCLOPRAMIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]18Current NDC, Legacy NDC, 2 package rows20250406_917494a9-cff1-4ee6-9523-e112120373c5.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDEHospira, Inc.146803a1-199d-4789-b128-e974bdd033222026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
METOCLOPRAMIDEMETOCLOPRAMIDEHF Acquisition Co LLC, DBA HealthFirst4046830f-4b87-5e6e-e063-6394a90aeeb82026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
MetoclopramideMETOCLOPRAMIDEHospira, Inc.373ba08b-33ad-49fc-28a7-928e89a653142026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
MetoclopramideMETOCLOPRAMIDEMedical Purchasing Solutions, LLC.41d9ee49-d434-5f9f-e063-6294a90afe0b2025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
MetoclopramideMETOCLOPRAMIDEProPharma Distribution3f2b17ea-c265-0cd4-e063-6294a90a9d882025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
MetoclopramideMETOCLOPRAMIDECardinal Health 107, LLC55b3fecb-f60c-474b-9530-915b0e68bf852025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
MetoclopramideMETOCLOPRAMIDECardinal Health 107, LLC917494a9-cff1-4ee6-9523-e112120373c52025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
ndc (product): 55154-2353
METOCLOPRAMIDEMETOCLOPRAMIDEHF Acquisition Co LLC, DBA HealthFirst7678bcd5-1071-0a9b-e053-2a91aa0a38532024-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118
MetoclopramideMETOCLOPRAMIDEMedical Purchasing Solutions, LLC79754097-4514-297e-e053-2991aa0a48042023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073118
application number: ANDA073118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2353-5551542353055 VIAL in 1 BAG (55154-2353-5) / 2 mL in 1 VIAL5 vial2009-09-220000-00-00NoNoCurrent