Prescription drug · ANDA
Metoclopramide NDC 50228-233
Metoclopramide hydrochloride 10 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-233-01 | 5022802330150228023301 | 100 TABLET in 1 BOTTLE (50228-233-01)Marketed from Feb 12, 2025 | |
| 50228-233-05 | 5022802330550228023305 | 500 TABLET in 1 BOTTLE (50228-233-05)Marketed from Feb 12, 2025 | |
| 50228-233-10 | 5022802331050228023310 | 1000 TABLET in 1 BOTTLE (50228-233-10)Marketed from Feb 12, 2025 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072215
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 50228-233_50b47676-8433-bfb9-e063-6394a90a124cSPL ID 50b47676-8433-bfb9-e063-6394a90a124cSPL set ID b16ad17c-eeea-407e-91e4-36506e9aa698RxCUI 311666, 311668UNII W1792A2RVDUPC 0350228232050, 0350228233057
- 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
N450228023301followed by a unit qualifier and the quantityPackage 50228-0233-01. 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. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use: Metoclopramide tablets have not been shown to be safe and effective for the treatment of gastroesophageal reflux for longer than 12 weeks. ( 1 , 5.1 ) Metoclopramide tablets are 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 methemoglobinemia in neonates. ( 1 , 8.4 ) Metoclopramide tablets are indicated for th…
Excerpt only. Read the full label for complete information.
About NDC 50228-233
- What is NDC 50228-233?
- 50228-233 is the product NDC for Metoclopramide, Metoclopramide hydrochloride 10 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 3 package NDCs, 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?
- ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 5 mg/1 | TabletOral | NuCare Pharamceuticals, Inc. | 68071-3924 | 68071-3924-03 |
Other NDCs under ANDA 072215
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 | ScieGen Pharmaceuticals, Inc. | 50228-232 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | NuCare Pharamceuticals, Inc. | 68071-3924 |