Prescription drug · ANDA
Metoclopramide NDC 66267-841
Metoclopramide hydrochloride 5 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66267-841-06 | 66267084106 | 6 TABLET in 1 BOTTLE (66267-841-06)Marketed from Jan 24, 2017 |
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
- NuCare Pharmaceuticals, Inc.
- 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 66267-841_1fa77075-a19b-971d-e063-6294a90a255dSPL ID 1fa77075-a19b-971d-e063-6294a90a255dSPL set ID 46dcafbc-9d50-316a-e054-00144ff88e88RxCUI 311668UNII W1792A2RVDUPC 0366267841061
- 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
N466267084106followed by a unit qualifier and the quantityPackage 66267-0841-06. 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, USP is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide tablets, USP 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…
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 | Teva Pharmaceuticals USA, Inc. | 0093-2204 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-0186 |
| 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 |