Prescription drug · ANDA
Metoclopramide NDC 53401-027
Metoclopramide hydrochloride 10 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-027-01 | 53401002701 | 1 TABLET in 1 BOTTLE (53401-027-01)Marketed from Aug 17, 2026 |
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
- 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 53401-027_59543a07-5813-821a-e063-6294a90ab735SPL ID 59543a07-5813-821a-e063-6294a90ab735SPL set ID 595439ae-cf01-821c-e063-6294a90af16aRxCUI 311666UNII 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
N453401002701followed by a unit qualifier and the quantityPackage 53401-0027-01. 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 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 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 | 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 | American Health Packaging | 60687-631 |
| 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 |