Prescription drug · ANDA
Metoclopramide (Metoclopramide hydrochloride) NDC 0121-0576
Metoclopramide hydrochloride 5 mg/5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0576-16 | 0012105761600121057616 | 473 mL in 1 BOTTLE (0121-0576-16)Marketed from Jun 1, 1991 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrochloride
- Active ingredients
- Metoclopramide hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- 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 0121-0576_9e77216c-c14e-4318-8569-288652321db9SPL ID 9e77216c-c14e-4318-8569-288652321db9SPL set ID 3cc8ca5b-8b71-4c77-a181-9ce154597b9aRxCUI 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.
- NDC on a medical claim
N400121057616followed by a unit qualifier and the quantityPackage 00121-0576-16. 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 is 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. Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methe…
Excerpt only. Read the full label for complete information.
About NDC 0121-0576
- What is NDC 0121-0576?
- 0121-0576 is the product NDC for Metoclopramide (metoclopramide hydrochloride), Metoclopramide hydrochloride 5 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoclopramide (Metoclopramide hydrochloride).
- What is the active ingredient?
- Metoclopramide hydrochloride.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 | 0121-1576 |
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0576 |
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Genus Lifesciences Inc. | 64950-344 |