Prescription drug · NDA
Gimoti (metoclopramide hydrochloride) NDC 72089-307
Metoclopramide hydrochloride 15 mg/.07mL · Spray · Nasal · Evoke Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72089-307-15 | 72089030715 | 1 BOTTLE, PUMP in 1 CARTON (72089-307-15) / 9.8 mL in 1 BOTTLE, PUMPMarketed from Jun 19, 2020 |
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)
- Gimoti
- Generic name (nonproprietary)
- metoclopramide hydrochloride
- Active ingredients
- Metoclopramide hydrochloride — 15 mg/.07mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Evoke Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209388
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine D2 Antagonists (Mechanism)
- Identifiers
- Product ID 72089-307_4b47dd3d-4a37-e136-e063-6394a90a31efSPL ID 4b47dd3d-4a37-e136-e063-6394a90a31efSPL set ID 95269b1f-779c-4ca0-9f86-e74e677f9900RxCUI 2380564, 2380570UNII 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472089030715followed by a unit qualifier and the quantityPackage 72089-0307-15. 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)
GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. GIMOTI is a dopamine-2 (D 2 ) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : GIMOTI is 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 ) moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased dr…
Excerpt only. Read the full label for complete information.