Metoclopramide

Product NDC: 70934-384
11-digit product format: 709340384
Labeler code: 70934
Product ID: 70934-384_b7af7491-fdc1-e6c8-e053-2995a90a96c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA070184
Marketing category: ANDA
Marketing start: 2019-06-03
Marketing end: 0000-00-00
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
86441fd8-22b8-41db-bb26-c70dffc3923b	Product name	1	20210111
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-384-06	2022-01-28	C162847	48780-1	d6a99b39-b5e3-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-384-06	Metoclopramide	6 in 1 BOTTLE, PLASTIC	TABLET	6		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-384	METOCLOPRAMIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20201231_95aceb69-720a-60fb-e053-2a95a90a8d4b.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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311666	metoclopramide HCl 10 MG Oral Tablet	PSN	95aceb69-720a-60fb-e053-2a95a90a8d4b	2
311666	metoclopramide 10 MG Oral Tablet	SCD	95aceb69-720a-60fb-e053-2a95a90a8d4b	2
311666	metoclopramide (as metoclopramide HCl) 10 MG Oral Tablet	SY	95aceb69-720a-60fb-e053-2a95a90a8d4b	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-384-06	70934038406	6 TABLET in 1 BOTTLE, PLASTIC (70934-384-06)	6 tablet	2019-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoclopramide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2