Metoclopramide

Product NDC
71335-0362
11-digit product format
713350362
Labeler code
71335
Product ID
71335-0362_21012b46-95dc-4a07-8b81-c623eb771740
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070184
Marketing category
ANDA
Marketing start
1990-09-30
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
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070184-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070184-001AB

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 UTC2026-02A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29cb3db0bc1861…

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 UTC2026-02A070184-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070184-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070184-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070184-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070184-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070184-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070184-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070184-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070184-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070184-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070184-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070184-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070184-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070184-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070184-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070184-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070184-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070184-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070184-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070184-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070184-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070184-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070184-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070184-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070184-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070184-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070184-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070184-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070184-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070184-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070184-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070184-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070184-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070184-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070184-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070184-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070184-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070184-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070184-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070184-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE10 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
311666Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
23f11d3c-1529-4bb6-a61e-e4bab1a3e98eAvailable 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
71335-0362-1Metoclopramide30 in 1 BOTTLETABLET3011
71335-0362-2Metoclopramide90 in 1 BOTTLETABLET9011
71335-0362-3Metoclopramide60 in 1 BOTTLETABLET6011
71335-0362-4Metoclopramide10 in 1 BOTTLETABLET1011
71335-0362-5Metoclopramide20 in 1 BOTTLETABLET2011
71335-0362-6Metoclopramide100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0362-1EA - Each71335-0362fd3c041a-4e12-47a2-894f-49492223766e12018-01-12
71335-0362-2EA - Each71335-0362a84e00c9-4f39-4526-83c7-f888d88de51212018-01-12
71335-0362-3EA - Each71335-03622f5da851-be9d-460f-b1b9-c4c1923b39db12018-01-12
71335-0362-4EA - Each71335-03620c968c2a-a9d7-4494-a3e6-00b710f0c4db12018-01-12
71335-0362-5EA - Each71335-03628fa0a613-0f52-4fa3-9c63-90a021c288e812018-01-12
71335-0362-6EA - Each71335-0362c7283172-d6d3-4a2c-bc08-405369c58ac512018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0362METOCLOPRAMIDE TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 6 package rows20240809_23f11d3c-1529-4bb6-a61e-e4bab1a3e98e.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDEREMEDYREPACK INC.5d31d815-50fa-4e78-8ebd-affc2514ce782026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEPreferred Pharmaceuticals Inc.697ec7b1-945a-4a31-b585-f051dc2461652026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDECoupler LLC5345905d-18b0-1e42-e063-6394a90af7452026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDESafecor Health LLC15d616d7-2f4c-4882-a03c-fcc86c18f5f82026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEREMEDYREPACK INC.6637cb78-d50a-4dbf-8fb7-b1b5102c5c5f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDETeva Pharmaceuticals USA, Inc.e15905e0-e0f6-4c8b-ac19-59724d6c4bf02026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEAvKAREff067ac5-6efc-3e86-e6d5-590b2779491c2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENorthwind Health Company, LLCf2b732ab-b859-7252-e053-2995a90af0d82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEMylan Institutional Inc.447dbb34-7903-4e6a-be31-48a0b0e0d2f52025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENCS HealthCare of KY, LLC dba Vangard Labs4ab8ddab-8226-4b5a-8774-308ed49d6bc42025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEAmerican Health Packaging998f1782-bbfa-469b-9fe1-c612e8588f702024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.40cf021d-5f2a-055c-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals,Inc.5d7cd5a0-4a84-4084-e053-2a91aa0a686f2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack23f11d3c-1529-4bb6-a61e-e4bab1a3e98e2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
ndc (product): 71335-0362
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack31da0c8b-8171-4bd2-9832-12ba85e36b372024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEA-S Medication Solutions264c4f48-51f4-458f-9e61-1adafdf604fc2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEProficient Rx LPce367a41-89d3-45c2-aac2-36fce43062d02023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN23f11d3c-1529-4bb6-a61e-e4bab1a3e98e11
311666metoclopramide 10 MG Oral TabletSCD23f11d3c-1529-4bb6-a61e-e4bab1a3e98e11
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY23f11d3c-1529-4bb6-a61e-e4bab1a3e98e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0362-17133503620130 TABLET in 1 BOTTLE (71335-0362-1) 30 tablet2018-09-060000-00-00NoNoCurrent
71335-0362-27133503620290 TABLET in 1 BOTTLE (71335-0362-2) 90 tablet2021-12-290000-00-00NoNoCurrent
71335-0362-37133503620360 TABLET in 1 BOTTLE (71335-0362-3) 60 tablet2021-12-290000-00-00NoNoCurrent
71335-0362-47133503620410 TABLET in 1 BOTTLE (71335-0362-4) 10 tablet2021-12-290000-00-00NoNoCurrent
71335-0362-57133503620520 TABLET in 1 BOTTLE (71335-0362-5) 20 tablet2021-12-290000-00-00NoNoCurrent
71335-0362-671335036206100 TABLET in 1 BOTTLE (71335-0362-6) 100 tablet2021-12-290000-00-00NoNoCurrent