Prescription drug · ANDA
Metoclopramide (Metoclopramide hydrochloride) NDC 83634-779
Metoclopramide hydrochloride 5 mg/mL · Injection, Solution · Intramuscular, Intravenous · Avenacy, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-779-02 | 8363407790283634077902 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-779-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-779-41)Marketed from Jun 30, 2024 |
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 hydrochloride
- Active ingredients
- Metoclopramide hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Avenacy, LLCNDC labeler code 83634
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204756
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 83634-779_620bde2b-b8c1-4c76-a2d1-acc0af3b5859SPL ID 620bde2b-b8c1-4c76-a2d1-acc0af3b5859SPL set ID dc4a13f8-1e9b-4c75-82c0-bcd11f0a9a66RxCUI 311670UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N483634077902followed by a unit qualifier and the quantityPackage 83634-0779-02. 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 Diabetic Gastroparesis Metoclopramide injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy Metoclopramide injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy in adults. The Prevention of Postoperative Nausea and Vomiting Metoclopramide injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable in adults. Small Bowel Intubation Metoclopramide injection i…
Excerpt only. Read the full label for complete information.
About NDC 83634-779
- What is NDC 83634-779?
- 83634-779 is the product NDC for Metoclopramide (metoclopramide hydrochloride), Metoclopramide hydrochloride 5 mg/mL injection, solution, listed with the FDA by Avenacy, LLC. 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?
- Avenacy, LLC, NDC labeler code 83634. 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 204756
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/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9771 |
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-240 |
| Metoclopramidemetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7265 |