Reglan (metoclopramide hydrochloride) NDC 62559-165

NDC codes

FDA NDC Directory

Product NDC (as listed)62559-165Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62559-0165Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
62559-165-01	62559016501	100 TABLET in 1 BOTTLE, PLASTIC (62559-165-01)Marketed from Jul 5, 2011

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Reglan
Generic name (nonproprietary): metoclopramide hydrochloride
Active ingredients: Metoclopramide hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 017854
Marketing start: Jul 5, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Dopamine D2 Antagonists (Mechanism)
Identifiers: Product ID 62559-165_a7ad286f-c235-42bb-bc51-3f33a17e8dfeSPL ID a7ad286f-c235-42bb-bc51-3f33a17e8dfeSPL set ID de55c133-eb08-4a35-91a2-5dc093027397RxCUI 207265, 207266, 311666, 311668UNII W1792A2RVDUPC 0362559165013, 0362559166010
Pharmacologic class: Dopamine-2 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462559016501 followed by a unit qualifier and the quantity

Package 62559-0165-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Reglan tablets are indicated for the: • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use : • Reglan has not been shown to be safe and effective for the treatment of symptomatic, documented gastroesophageal reflux for longer than 12 weeks [see Warnings and Precautions ( 5.1 )] . • Reglan tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populati…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017854

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 017854
Product	Strength	Form · route	Labeler	Product NDC
Reglanmetoclopramide hydrochloride	Metoclopramide hydrochloride 10 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-166
Metoclopramide	Metoclopramide hydrochloride 5 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-295
Metoclopramide	Metoclopramide hydrochloride 10 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-296
Metoclopramide	Metoclopramide hydrochloride 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4541
Metoclopramide	Metoclopramide hydrochloride 5 mg/1	TabletOral	Redpharm Drug	67296-2213