Metoclopramide

Product NDC
71335-1259
Requested package NDC
71335-1259-3
11-digit product format
713351259
Labeler code
71335
Product ID
71335-1259_e2c63d5f-9d75-4e3d-9278-dbffa09fd944
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-125971335-1259-3DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
6f0a13cc-9346-4f4a-9a0d-b725045b01aaAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1259-1Metoclopramide30 in 1 BOTTLETABLET30100
71335-1259-2Metoclopramide120 in 1 BOTTLETABLET120100
71335-1259-3Metoclopramide90 in 1 BOTTLETABLET90100
71335-1259-4Metoclopramide60 in 1 BOTTLETABLET60100
71335-1259-5Metoclopramide100 in 1 BOTTLETABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1259METOCLOPRAMIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, Legacy NDC, 5 package rows20240526_6f0a13cc-9346-4f4a-9a0d-b725045b01aa.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
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack6f0a13cc-9346-4f4a-9a0d-b725045b01aa2024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
ndc (package): 71335-1259-3
ndc (product): 71335-1259
ndc11 (package): 71335125903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311668metoclopramide HCl 5 MG Oral TabletPSN6f0a13cc-9346-4f4a-9a0d-b725045b01aa100
311668metoclopramide 5 MG Oral TabletSCD6f0a13cc-9346-4f4a-9a0d-b725045b01aa100
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY6f0a13cc-9346-4f4a-9a0d-b725045b01aa100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1259-37133512590390 TABLET in 1 BOTTLE (71335-1259-3) 90 tablet2024-05-240000-00-00NoNoCurrent