Home NDC 62559-165 Reglan
Product NDC 62559-165
11-digit product format 625590165
Labeler code 62559
Product ID 62559-165_a7ad286f-c235-42bb-bc51-3f33a17e8dfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoclopramide Hydrochloride
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA017854
Marketing category NDA
Marketing start 2011-07-05
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017854-001 REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 N017854-002 REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N017854-001 REGLAN EQ 10MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N017854-002 REGLAN EQ 5MG BASE TABLET / ORAL AB RLD 1987-05-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Reglan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207265 Internal RxNorm lookup 207266 Internal RxNorm lookup 311666 Internal RxNorm lookup 311668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62559-165-01 Reglan 100 in 1 BOTTLE, PLASTIC TABLET 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METOCLOPRAMIDE HYDROCHLORIDE ACTIVE INGREDIENT W1792A2RVD REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 METOCLOPRAMIDE ACTIVE MOIETY L4YEB44I46 REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 LACTOSE INACTIVE INGREDIENT J2B2A4N98G REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-165 REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20200618_de55c133-eb08-4a35-91a2-5dc093027397.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metoclopramide METOCLOPRAMIDE ANI Pharmaceuticals, Inc. 797aad80-0597-42f8-99d5-39de180c3b5a 2026-05-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017854 application number: NDA017854 Reglan METOCLOPRAMIDE HYDROCHLORIDE ANI Pharmaceuticals, Inc. de55c133-eb08-4a35-91a2-5dc093027397 2026-02-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017854 application number: NDA017854 ndc (product): 62559-165 Metoclopramide METOCLOPRAMIDE Redpharm Drug 49eb807b-fa34-3d84-e063-6394a90acfcf 2026-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017854 application number: NDA017854 Metoclopramide METOCLOPRAMIDE REMEDYREPACK INC. c4828095-94e0-4f71-901c-93837974c658 2025-12-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017854 application number: NDA017854
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62559-165-01 62559016501 100 TABLET in 1 BOTTLE, PLASTIC (62559-165-01) 100 tablet 2011-07-05 0000-00-00 No No Current