Prescription drug · ANDA
Metoclopramide NDC 62559-190
Metoclopramide hydrochloride 5 mg/5mL · Solution · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-190-16 | 62559019016 | 473 mL in 1 BOTTLE, PLASTIC (62559-190-16)Marketed from May 18, 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
- Generic name (nonproprietary)
- metoclopramide
- Active ingredients
- Metoclopramide hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071402
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 62559-190_b140243d-3e3b-4a75-b55a-e224774af49fSPL ID b140243d-3e3b-4a75-b55a-e224774af49fSPL set ID 4e12e98a-06fe-4b3c-bb64-f2701e195c74RxCUI 104884UNII W1792A2RVDUPC 0362559190169
- 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
N462559019016followed by a unit qualifier and the quantityPackage 62559-0190-16. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of post-prandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071402
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Metoclopramide | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-1190 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Bryant Ranch Prepack | 63629-2144 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-1750 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | American Health Packaging | 60687-837 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Bryant Ranch Prepack | 71335-2732 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Bryant Ranch Prepack | 71335-2997 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Bryant Ranch Prepack | 63629-1961 |