Prescription drug · ANDA
Metoclopramide NDC 67046-0186
Metoclopramide hydrochloride 5 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0186-3 | 67046018603 | 30 TABLET in 1 BLISTER PACK (67046-0186-3)Marketed from Jun 2, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072801
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 67046-0186_5345a08f-bfed-cf49-e063-6294a90aacf2SPL ID 5345a08f-bfed-cf49-e063-6294a90aacf2SPL set ID 5345a125-0cee-472e-e063-6394a90aeb21RxCUI 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
N467046018603followed by a unit qualifier and the quantityPackage 67046-0186-03. 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 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 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 072801
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/1 | TabletOral | Mylan Institutional Inc. | 51079-886 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1259 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-841 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2204 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3923 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-620 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4383 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7698 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Safecor Health LLC | 48433-066 |