Metoclopramide NDC 0121-1576

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1576Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1576Add 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
0121-1576-10	00121157610	10 TRAY in 1 CASE (0121-1576-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSEMarketed from Jun 1, 1991

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Metoclopramide
Generic name (nonproprietary): metoclopramide hydrochloride
Active ingredients: Metoclopramide hydrochloride — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072744
Marketing start: Jun 1, 1991
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine D2 Antagonists (Mechanism)
Identifiers: Product ID 0121-1576_9e77216c-c14e-4318-8569-288652321db9SPL ID 9e77216c-c14e-4318-8569-288652321db9SPL set ID 3cc8ca5b-8b71-4c77-a181-9ce154597b9aRxCUI 104884UNII W1792A2RVD
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

N400121157610 followed by a unit qualifier and the quantity

Package 00121-1576-10. 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 Nov 13, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Metoclopramide is 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. Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072744

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

FDA NDC Directory listings under ANDA 072744
Product	Strength	Form · route	Labeler	Product NDC
Metoclopramidemetoclopramide hydrochloride	Metoclopramide hydrochloride 5 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0576
Metoclopramidemetoclopramide hydrochloride	Metoclopramide hydrochloride 5 mg/5mL	SolutionOral	Genus Lifesciences Inc.	64950-344
Metoclopramidemetoclopramide hydrochloride	Metoclopramide hydrochloride 5 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0576

Metoclopramide (metoclopramide hydrochloride) NDC 0121-1576