Home NDC 36000-366 METOCLOPRAMIDE
Product NDC 36000-366
11-digit product format 360000366
Labeler code 36000
Product ID 36000-366_f6efdc63-a9df-4bbd-acf8-75fc9d1b0347
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METOCLOPRAMIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA217072
Marketing category ANDA
Marketing start 2026-09-11
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A217072-001 METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2026-09-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217072-001 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.
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 2026-10-15 13:18:30 2026-09 A217072-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2026-09-11 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A217072-001 AP 1 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base METOCLOPRAMIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 36000-366-25 36000036625 25 VIAL, SINGLE-DOSE in 1 CARTON (36000-366-25) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-366-01) 2026-09-11 No No Current