Metoclopramide

Product NDC
66267-841
11-digit product format
662670841
Labeler code
66267
Product ID
66267-841_1fa77075-a19b-971d-e063-6294a90a255d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA072801
Marketing category
ANDA
Marketing start
1993-07-01
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
2026-12-31
Current FDA listing
Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-841-06557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-841-068af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-841-06834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-841-061332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072801-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072801-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072801-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072801-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072801-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072801-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072801-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072801-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072801-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072801-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072801-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072801-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072801-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072801-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072801-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072801-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072801-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072801-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072801-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072801-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072801-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072801-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072801-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072801-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072801-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072801-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072801-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072801-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072801-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072801-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072801-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072801-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072801-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072801-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072801-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072801-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072801-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072801-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072801-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072801-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072801-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072801-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoclopramide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W1792A2RVDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46dcafbc-9d50-316a-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86441fd8-22b8-41db-bb26-c70dffc3923bProduct name120210111
340a6817-217a-4b71-9e83-8e2e60c4b0c5Product name120150319
1f2c49ec-0a44-8021-ecde-b27ece080b13Product name120140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-841-062024-08-14C16284748780-1f386c649-f782-0266-e053-dadaa90a7c1aMETOCLOPRAMIDE TABLETS, USP 2204 2203 Rx only
66267-841-062023-01-30C16284748780-1f386c649-f782-0266-e053-dadaa90a7c1aMETOCLOPRAMIDE TABLETS, USP 2204 2203 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-841-06Metoclopramide6 in 1 BOTTLETABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-841METOCLOPRAMIDE TABLET [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240816_46dcafbc-9d50-316a-e054-00144ff88e88.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDECardinal Health 107, LLC7eeaa7bc-c94f-47d0-94e5-e35ccadca19e2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDECoupler LLC5345a125-0cee-472e-e063-6394a90aeb212026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDESafecor Health LLC15d616d7-2f4c-4882-a03c-fcc86c18f5f82026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDETeva Pharmaceuticals USA, Inc.e15905e0-e0f6-4c8b-ac19-59724d6c4bf02026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.4524146c-f588-083b-e063-6294a90ac9772025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDEMylan Institutional Inc.447dbb34-7903-4e6a-be31-48a0b0e0d2f52025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDENCS HealthCare of KY, LLC dba Vangard Labs4ab8ddab-8226-4b5a-8774-308ed49d6bc42025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDEAmerican Health Packaging998f1782-bbfa-469b-9fe1-c612e8588f702024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.46dcafbc-9d50-316a-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
ndc (product): 66267-841
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack6f0a13cc-9346-4f4a-9a0d-b725045b01aa2024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311668metoclopramide HCl 5 MG Oral TabletPSN46dcafbc-9d50-316a-e054-00144ff88e884
311668metoclopramide 5 MG Oral TabletSCD46dcafbc-9d50-316a-e054-00144ff88e884
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY46dcafbc-9d50-316a-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-841-06662670841066 TABLET in 1 BOTTLE (66267-841-06) 6 tablet2017-01-240000-00-00NoNoCurrent