Prescription drug · ANDA
Metoclopramide NDC 51079-886
Metoclopramide hydrochloride 5 mg/1 · Tablet · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-886-20 | 51079088620 | 100 BLISTER PACK in 1 CARTON (51079-886-20) / 1 TABLET in 1 BLISTER PACK (51079-886-01)Marketed from Dec 30, 2013 |
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
- Mylan Institutional 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 51079-886_3a866de8-d779-26e4-e063-6294a90abf6bSPL ID 3a866de8-d779-26e4-e063-6294a90abf6bSPL set ID 447dbb34-7903-4e6a-be31-48a0b0e0d2f5RxCUI 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
N451079088620followed by a unit qualifier and the quantityPackage 51079-0886-20. 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 conv…
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 | 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 | 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 |