Home NDC 55154-0450 Metoclopramide
Product NDC 55154-0450
11-digit product format 551540450
Labeler code 55154
Product ID 55154-0450_40f91221-fbfc-4cf1-aa80-d5dad90ea005
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoclopramide
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Cardinal Health 107, LLC
Application ANDA073135
Marketing category ANDA
Marketing start 1993-12-10
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073135-001 METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073135-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073135-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1991-11-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metoclopramide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W1792A2RVD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311670 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-0450-5 Metoclopramide 5 in 1 BAG INJECTION, SOLUTION 5 10 55154-0450-5 Metoclopramide 2 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 2 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-0450 METOCLOPRAMIDE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240202_1ecab710-8b7d-4903-80a8-de66562be55a.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metoclopramide METOCLOPRAMIDE Teva Parenteral Medicines, Inc. cccf04bd-7463-40b8-a41f-cb1093c358d7 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073135 application number: ANDA073135 Metoclopramide METOCLOPRAMIDE Teva Parenteral Medicines, Inc. 5645a752-8868-4b51-8b59-48bb4276d763 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073135 application number: ANDA073135 Metoclopramide METOCLOPRAMIDE Cardinal Health 107, LLC 1ecab710-8b7d-4903-80a8-de66562be55a 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073135 application number: ANDA073135 ndc (product): 55154-0450
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-0450-5 55154045005 5 VIAL, SINGLE-USE in 1 BAG (55154-0450-5) / 2 mL in 1 VIAL, SINGLE-USE 1993-12-10 0000-00-00 No No Current