Prescription drug · ANDA
Metoclopramide NDC 63187-404
Metoclopramide hydrochloride 5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-404-12 | 63187040412 | 12 TABLET in 1 BOTTLE (63187-404-12)Marketed from Jan 20, 2023 | |
| 63187-404-30 | 63187040430 | 30 TABLET in 1 BOTTLE (63187-404-30)Marketed from Nov 1, 2014 | |
| 63187-404-60 | 63187040460 | 60 TABLET in 1 BOTTLE (63187-404-60)Marketed from Nov 1, 2014 | |
| 63187-404-90 | 63187040490 | 90 TABLET in 1 BOTTLE (63187-404-90)Marketed from Nov 1, 2014 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-404_99c5f2dc-5112-4a12-9d4e-cdd0f4936ec1SPL ID 99c5f2dc-5112-4a12-9d4e-cdd0f4936ec1SPL set ID ce367a41-89d3-45c2-aac2-36fce43062d0RxCUI 311666, 311668UNII W1792A2RVDUPC 0363187404307, 0363187235123
- 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
N463187040412followed by a unit qualifier and the quantityPackage 63187-0404-12. 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 tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide tablets are 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 postprandial 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 than using the…
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 | American Health Packaging | 60687-631 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1193 |
| 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 |