METOCLOPRAMIDE hydrochloride NDC 43386-581

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0581Add 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
43386-581-31	43386058131	1 BLISTER PACK in 1 CARTON (43386-581-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Apr 6, 2015

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): METOCLOPRAMIDE hydrochloride
Generic name (nonproprietary): metoclopramide hydrochloride
Active ingredients: Metoclopramide hydrochloride — 5 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202191
Marketing start: Apr 6, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine D2 Antagonists (Mechanism)
Identifiers: Product ID 43386-581_b5844be2-94b3-3e3f-e053-2995a90a6eb8SPL ID b5844be2-94b3-3e3f-e053-2995a90a6eb8SPL set ID 7cd1dc35-2fb2-4f1d-8769-24c3c3aa34faRxCUI 608623, 608624UNII 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

N443386058131 followed by a unit qualifier and the quantity

Package 43386-0581-31. 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 Dec 2, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Metoclopramide Orally Disintegrating Tablets is indicated in adults for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. Relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis). Limitations of Use : Metoclopramide Orally Disintegrating Tablets is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms and the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )] Metoclopramide Orally Disintegrating Tablets is a dopamine-2 (D2) antagonist indicated in adults …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202191

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

FDA NDC Directory listings under ANDA 202191
Product	Strength	Form · route	Labeler	Product NDC
METOCLOPRAMIDE hydrochloride	Metoclopramide hydrochloride 10 mg/1	Tablet, Orally disintegratingOral	Lupin Pharmaceuticals,Inc.	43386-580