metoclopramide hydrochloride

Product NDC: 62135-526
11-digit product format: 621350526
Labeler code: 62135
Product ID: 62135-526_49dc78f2-e942-afb5-e063-6394a90a20d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metoclopramide hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA073680
Marketing category: ANDA
Marketing start: 1992-10-27
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: 2027-12-31
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
A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL			1992-10-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073680-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	1992-10-27	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: metoclopramide hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOCLOPRAMIDE HYDROCHLORIDE	5 mg/5mL

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
104884	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dc364325-dd39-4259-a348-3760eccdca4b	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62135-526-10	metoclopramide hydrochloride	10 mL in 1 CUP	SOLUTION	10	3
62135-526-24	metoclopramide hydrochloride	2 in 1 BOX	SOLUTION	2	3
62135-526-24	metoclopramide hydrochloride	10 in 1 TRAY	SOLUTION	10	3
62135-526-47	metoclopramide hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-526-10	ML - Milliliter	62135-526	6d141b8e-77e3-46d0-bff6-2973033b8423	1	2024-12-10
62135-526-24	ML - Milliliter	62135-526	1c73cc17-7de7-45cb-b2be-77bf19f4ca0a	1	2024-12-10
62135-526-47	ML - Milliliter	62135-526	43bc1ce9-607f-4a0c-88e3-a7cbc33889ee	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-526	METOCLOPRAMIDE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]	2	Current NDC, 4 package rows	20241024_dc364325-dd39-4259-a348-3760eccdca4b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metoclopramide hydrochloride	METOCLOPRAMIDE HYDROCHLORIDE	Chartwell RX, LLC	dc364325-dd39-4259-a348-3760eccdca4b	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073680 application number: ANDA073680 ndc (product): 62135-526
metoclopramide hydrochloride	METOCLOPRAMIDE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	c4ab34f2-25e6-47bd-9dde-1f4baf469f0d	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073680 application number: ANDA073680

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

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	dc364325-dd39-4259-a348-3760eccdca4b	3
104884	metoclopramide 1 MG/ML Oral Solution	SCD	dc364325-dd39-4259-a348-3760eccdca4b	3
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	dc364325-dd39-4259-a348-3760eccdca4b	3
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	dc364325-dd39-4259-a348-3760eccdca4b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-526-10	62135052610	10 mL in 1 CUP	10 ml				Historical
62135-526-24	62135052624	2 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10)	2 tray	2024-10-14	No	No	Current
62135-526-47	62135052647	473 mL in 1 BOTTLE (62135-526-47)	473 ml	2023-03-21	No	No	Current