Prescription drug · NDA AUTHORIZED GENERIC
Metoclopramide NDC 62559-296
Metoclopramide hydrochloride 10 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-296-01 | 62559029601 | 100 TABLET in 1 BOTTLE, PLASTIC (62559-296-01)Marketed from Dec 13, 2021 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017854
- Marketing start
- Marketing end
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 62559-296_6d4ed2af-6756-4e7a-8325-820490408f5fSPL ID 6d4ed2af-6756-4e7a-8325-820490408f5fSPL set ID 797aad80-0597-42f8-99d5-39de180c3b5aRxCUI 311666, 311668UNII W1792A2RVDUPC 0362559295017, 0362559296014
- 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
N462559029601followed by a unit qualifier and the quantityPackage 62559-0296-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Metoclopramide Tablets USP 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 : • Metoclopramide Tablets USP have 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 )] . • Metoclopramide Tablets USP 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 methemoglobine…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 017854
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 |
|---|---|---|---|---|
| Reglanmetoclopramide hydrochloride | Metoclopramide hydrochloride 10 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-166 |
| Reglanmetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-165 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-295 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4541 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Redpharm Drug | 67296-2213 |