Prescription drug · NDA
Reglan (Metoclopramide hydrochloride) NDC 62559-166
Metoclopramide hydrochloride 10 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-166-01 | 6255901660162559016601 | 100 TABLET in 1 BOTTLE, PLASTIC (62559-166-01)Marketed from Jul 5, 2011 |
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)
- Reglan
- Generic name (nonproprietary)
- metoclopramide hydrochloride
- Active ingredients
- Metoclopramide hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017854
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 62559-166_a7ad286f-c235-42bb-bc51-3f33a17e8dfeSPL ID a7ad286f-c235-42bb-bc51-3f33a17e8dfeSPL set ID de55c133-eb08-4a35-91a2-5dc093027397RxCUI 207265, 207266, 311666, 311668UNII W1792A2RVDUPC 0362559165013, 0362559166010
- 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
N462559016601followed by a unit qualifier and the quantityPackage 62559-0166-01. 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)
Reglan 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 : • Reglan has not been shown to be safe and effective for the treatment of symptomatic, documented gastroesophageal reflux for longer than 12 weeks [see Warnings and Precautions ( 5.1 )] . • Reglan 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 Populati…
Excerpt only. Read the full label for complete information.
About NDC 62559-166
- What is NDC 62559-166?
- 62559-166 is the product NDC for Reglan (metoclopramide hydrochloride), Metoclopramide hydrochloride 10 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Reglan (Metoclopramide Hydrochloride).
- What is the active ingredient?
- Metoclopramide hydrochloride.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Reglan?
- 1 other product NDC are listed under this name. See all Reglan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Reglan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Reglanmetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-165 | 62559-0165-01 |
Other NDCs under NDA 017854
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 | ANI Pharmaceuticals, Inc. | 62559-295 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-296 |
| Metoclopramide | Metoclopramide hydrochloride 5 mg/1 | TabletOral | Redpharm Drug | 67296-2213 |
| Metoclopramide | Metoclopramide hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4541 |
| Reglanmetoclopramide hydrochloride | Metoclopramide hydrochloride 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-165 |