Metoclopramide Hydrochloride

Product NDC: 68071-4551
11-digit product format: 680714551
Labeler code: 68071
Product ID: 68071-4551_bbb96cee-2ece-dd43-e053-2995a90a31bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA072750
Marketing category: ANDA
Marketing start: 2011-08-22
Marketing end: 0000-00-00
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-4551		D	Discontinued by firm	2026-10-12
excluded package	package	68071-4551	68071-4551-1	D	Discontinued by firm	2026-10-12
excluded package	package	68071-4551	68071-4551-6	D	Discontinued by firm	2026-10-12
excluded package	package	68071-4551	68071-4551-8	D	Discontinued by firm	2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4551-6	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4551-8	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4551-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4551-6	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4551-8	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4551-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4551-6	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4551-8	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4551-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4551-6	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4551-8	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4551-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4551-6	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4551-8	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4551-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4551-6	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4551-8	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4551-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4551-6	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4551-8	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4551-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4551-6	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4551-8	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4551-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4551-6	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4551-8	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4551-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4551-6	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4551-8	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4551-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-4551-6	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-4551-8	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-4551-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-4551-6	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-4551-8	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-4551-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4551-6	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4551-8	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4551-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4551-6	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4551-8	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4551-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4551-6	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4551-8	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4551-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-4551-1	2024-06-11	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-6	2024-06-11	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-8	2024-06-11	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-1	2023-01-30	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-6	2023-01-30	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-8	2023-01-30	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-1	2021-02-19	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-6	2021-02-19	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-8	2021-02-19	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-1	2021-01-29	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-6	2021-01-29	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979
68071-4551-8	2021-01-29	These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS, USP safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS, USP. METAOCLOPRAMIDE tablets, USP, for oral use Initial U.S. Approval: 1979

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W1792A2RVD	METOCLOPRAMIDE HYDROCHLORIDE	54143-57-6	METOCLOPRAMIDE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4551-1	68071455101	10 TABLET in 1 BOTTLE (68071-4551-1)	10 tablet	2018-09-06	0000-00-00	No	No	Current
68071-4551-6	68071455106	6 TABLET in 1 BOTTLE (68071-4551-6)	6 tablet	2018-09-06	0000-00-00	No	No	Current
68071-4551-8	68071455108	8 TABLET in 1 BOTTLE (68071-4551-8)	8 tablet	2018-09-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoclopramide Hydrochloride	NuCare Pharmaceuticals,Inc.	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	2

Metoclopramide Hydrochloride

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#