Prescription drug · ANDA
metoclopramide hydrochloride NDC 62135-526
Metoclopramide hydrochloride 5 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-526-24 | 6213505262462135052624 | 2 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10)Marketed from Oct 14, 2024 | |
| 62135-526-47 | 6213505264762135052647 | 473 mL in 1 BOTTLE (62135-526-47)Marketed from Mar 21, 2023 |
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 hydrochloride
- Generic name (nonproprietary)
- metoclopramide hydrochloride
- Active ingredients
- Metoclopramide hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073680
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 62135-526_49dc78f2-e942-afb5-e063-6394a90a20d5SPL ID 49dc78f2-e942-afb5-e063-6394a90a20d5SPL set ID dc364325-dd39-4259-a348-3760eccdca4bRxCUI 104884UNII W1792A2RVDUPC 0362135526474
- 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
N462135052624followed by a unit qualifier and the quantityPackage 62135-0526-24. 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 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 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 tha…
Excerpt only. Read the full label for complete information.
About NDC 62135-526
- What is NDC 62135-526?
- 62135-526 is the product NDC for metoclopramide hydrochloride, Metoclopramide hydrochloride 5 mg/5mL solution, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- metoclopramide hydrochloride.
- What is the active ingredient?
- Metoclopramide hydrochloride.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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 hydrochloride?
- 3 other product NDCs are listed under this name. See all metoclopramide hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other metoclopramide hydrochloride 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 hydrochloride | Metoclopramide hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Lupin Pharmaceuticals,Inc. | 43386-580 | 43386-0580-31 |
| METOCLOPRAMIDE hydrochloride | Metoclopramide hydrochloride 5 mg/1 | Tablet, Orally disintegratingOral | Lupin Pharmaceuticals,Inc. | 43386-581 | 43386-0581-31 |
| metoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-526 | 68999-0526-24 |
Other NDCs under ANDA 073680
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 hydrochloride | Metoclopramide hydrochloride 5 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-526 |