Prescription drug · ANDA
Metoclopramide NDC 55154-4383
Metoclopramide hydrochloride 5 mg/1 · Tablet · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4383-0 | 5515443830055154438300 | 10 BLISTER PACK in 1 BAG (55154-4383-0) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 30, 2013 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLCNDC labeler code 55154
- 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 55154-4383_b09a00b4-cbf4-4248-8805-bcafd8a0e5acSPL ID b09a00b4-cbf4-4248-8805-bcafd8a0e5acSPL set ID 7eeaa7bc-c94f-47d0-94e5-e35ccadca19eRxCUI 311668UNII W1792A2RVDUPC 0055154438308
- 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
N455154438300followed by a unit qualifier and the quantityPackage 55154-4383-00. 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 t…
Excerpt only. Read the full label for complete information.
About NDC 55154-4383
- What is NDC 55154-4383?
- 55154-4383 is the product NDC for Metoclopramide, Metoclopramide hydrochloride 5 mg/1 tablet, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoclopramide.
- What is the active ingredient?
- Metoclopramide hydrochloride.
- Who is the labeler?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 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 | Teva Pharmaceuticals USA, Inc. | 0093-2204 |
| 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 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-886 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-620 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-841 |
| 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 | Bryant Ranch Prepack | 71335-1259 |