Metoclopramide

Product NDC: 62559-190
11-digit product format: 625590190
Labeler code: 62559
Product ID: 62559-190_b140243d-3e3b-4a75-b55a-e224774af49f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide
Dosage form: SOLUTION
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA071402
Marketing category: ANDA
Marketing start: 2015-05-18
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 5 mg/5mL
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

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/5mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	W1792A2RVD
Rxcui	104884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
86441fd8-22b8-41db-bb26-c70dffc3923b	Product name	1	20210111
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
340a6817-217a-4b71-9e83-8e2e60c4b0c5	Product name	1	20150319
1f2c49ec-0a44-8021-ecde-b27ece080b13	Product name	1	20140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62559-190-16	Metoclopramide	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-190-16	ML - Milliliter	62559-190	f0e7e36d-4e81-4109-a6d0-bdf30b2f3dca	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METOCLOPRAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	W1792A2RVD	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
METOCLOPRAMIDE	ACTIVE MOIETY	L4YEB44I46	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-190	METOCLOPRAMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20191101_4e12e98a-06fe-4b3c-bb64-f2701e195c74.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W1792A2RVD	METOCLOPRAMIDE HYDROCHLORIDE	54143-57-6	METOCLOPRAMIDE HYDROCHLORIDE
L4YEB44I46	METOCLOPRAMIDE	364-62-5	Metoclopramide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	9530014b-c266-4015-9195-9f100d67317b	104
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	67024bbc-65d1-428d-a807-46647038daf6	104
104884	metoclopramide 1 MG/ML Oral Solution	SCD	67024bbc-65d1-428d-a807-46647038daf6	104
104884	metoclopramide 1 MG/ML Oral Solution	SCD	9530014b-c266-4015-9195-9f100d67317b	104
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	9530014b-c266-4015-9195-9f100d67317b	104
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	67024bbc-65d1-428d-a807-46647038daf6	104
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	9530014b-c266-4015-9195-9f100d67317b	104
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	67024bbc-65d1-428d-a807-46647038daf6	104
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	14114420-fee0-4850-b99e-cdb5f421cd33	103
104884	metoclopramide 1 MG/ML Oral Solution	SCD	14114420-fee0-4850-b99e-cdb5f421cd33	103
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	14114420-fee0-4850-b99e-cdb5f421cd33	103
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	14114420-fee0-4850-b99e-cdb5f421cd33	103
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	e34fea34-5fc5-4200-bc9d-f5e558023630	100
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	84ec68c1-efa0-4ed2-9fae-d0cc17b0a6b4	100
104884	metoclopramide 1 MG/ML Oral Solution	SCD	84ec68c1-efa0-4ed2-9fae-d0cc17b0a6b4	100
104884	metoclopramide 1 MG/ML Oral Solution	SCD	e34fea34-5fc5-4200-bc9d-f5e558023630	100
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	84ec68c1-efa0-4ed2-9fae-d0cc17b0a6b4	100
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	e34fea34-5fc5-4200-bc9d-f5e558023630	100
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	84ec68c1-efa0-4ed2-9fae-d0cc17b0a6b4	100
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	e34fea34-5fc5-4200-bc9d-f5e558023630	100
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	4e12e98a-06fe-4b3c-bb64-f2701e195c74	5
104884	metoclopramide 1 MG/ML Oral Solution	SCD	4e12e98a-06fe-4b3c-bb64-f2701e195c74	5
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	4e12e98a-06fe-4b3c-bb64-f2701e195c74	5
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	4e12e98a-06fe-4b3c-bb64-f2701e195c74	5
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	0034a97a-fb05-418a-a234-de278907cd2a	4
104884	metoclopramide 1 MG/ML Oral Solution	SCD	0034a97a-fb05-418a-a234-de278907cd2a	4
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	0034a97a-fb05-418a-a234-de278907cd2a	4
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	0034a97a-fb05-418a-a234-de278907cd2a	4
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	3ce3245f-7021-5135-e063-6394a90a7d95	2
104884	metoclopramide 1 MG/ML Oral Solution	SCD	3ce3245f-7021-5135-e063-6394a90a7d95	2
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	3ce3245f-7021-5135-e063-6394a90a7d95	2
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	3ce3245f-7021-5135-e063-6394a90a7d95	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-190-16	62559019016	473 mL in 1 BOTTLE, PLASTIC (62559-190-16)	473 ml	2015-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	Bryant Ranch Prepack	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	100
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	ATLANTIC BIOLOGICALS CORP.	2025-08-21	HUMAN PRESCRIPTION DRUG LABEL	2
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	Bryant Ranch Prepack	2025-08-18	HUMAN PRESCRIPTION DRUG LABEL	104
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	Bryant Ranch Prepack	2025-08-18	HUMAN PRESCRIPTION DRUG LABEL	103
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	Bryant Ranch Prepack	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	100
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	ANI Pharmaceuticals, Inc.	2025-06-20	HUMAN PRESCRIPTION DRUG LABEL	5
Metoclopramide Oral Solution USP Rx Only 8483756/0324F	American Health Packaging	2025-04-11	HUMAN PRESCRIPTION DRUG LABEL	4
Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only	Bryant Ranch Prepack	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	104

Metoclopramide

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#