Prescription drug · ANDA
Metoclopramide (Metoclopramide hydrochloride) NDC 17856-0576
Metoclopramide hydrochloride 5 mg/5mL · Solution · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Metoclopramide
- Generic name (nonproprietary)
- metoclopramide hydrochloride
- Active ingredients
- Metoclopramide hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072744
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 17856-0576_56433a5f-85b5-0569-e063-6294a90ac304SPL ID 56433a5f-85b5-0569-e063-6294a90ac304SPL set ID 3cd4b274-6176-4e5b-9765-4f50763bd58fRxCUI 104884UNII 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.
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 Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution USP is 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…
Excerpt only. Read the full label for complete information.
About NDC 17856-0576
- What is NDC 17856-0576?
- 17856-0576 is the product NDC for Metoclopramide (metoclopramide hydrochloride), Metoclopramide hydrochloride 5 mg/5mL solution, listed with the FDA by ATLANTIC BIOLOGICALS CORP..
- What drug is associated with this NDC?
- Metoclopramide (Metoclopramide hydrochloride).
- What is the active ingredient?
- Metoclopramide hydrochloride.
- Who is the labeler?
- ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metoclopramide?
- 71 other product NDCs are listed under this name. See all Metoclopramide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metoclopramide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metoclopramide | Metoclopramide hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 36000-366 | 36000-0366-25 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-0186 | 67046-0186-03 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Coupler LLC | 67046-0581 | 67046-0581-03 |
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9771 | 00404-9771-02 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Safecor Health LLC | 48433-066 | 48433-0066-20 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | Safecor Health LLC | 48433-067 | 48433-0067-20 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4541 | 70518-4541-00 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-7832 | 55154-7832-05 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-232 | 50228-0232-0150228-0232-05 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-233 | 50228-0233-0150228-0233-0550228-0233-10 |
Other NDCs under ANDA 072744
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 |
|---|---|---|---|---|
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0576 |
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1576 |
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Genus Lifesciences Inc. | 64950-344 |