Prescription drug · ANDA
Metoclopramide NDC 60687-631
Metoclopramide hydrochloride 10 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-631-01 | 60687063101 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-631-01) / 1 TABLET in 1 BLISTER PACK (60687-631-11)Marketed from Jan 24, 2022 |
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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070184
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 60687-631_223f574d-b64f-236d-e063-6294a90aada1SPL ID 223f574d-b64f-236d-e063-6294a90aada1SPL set ID 998f1782-bbfa-469b-9fe1-c612e8588f70RxCUI 311666, 311668UNII 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
N460687063101followed by a unit qualifier and the quantityPackage 60687-0631-01. 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 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 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 Populations (8.4) ]. Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to convent…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070184
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 10 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-888 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8745 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-286 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7930 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-027 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2203 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-827 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 63187-235 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0669 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0362 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8285 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Coupler LLC | 67046-0581 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1193 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Proficient Rx LP | 63187-404 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-240 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | AvKARE | 42291-596 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0132 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Safecor Health LLC | 48433-067 |