Prescription drug · NDA
Enbumyst (Bumetanide) NDC 84388-005
Bumetanide .5 mg/.1mL · Spray · Nasal · Corstasis USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84388-005-12 | 8438800051284388000512 | 2 CARTON in 1 CARTON (84388-005-12) / 6 PACKAGE in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 PACKAGE / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 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)
- Enbumyst
- Generic name (nonproprietary)
- bumetanide
- Active ingredients
- Bumetanide — .5 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Corstasis USA LLCNDC labeler code 84388
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219500
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 84388-005_36587302-f02b-4a6c-a5f5-be52ea98c8d9SPL ID 36587302-f02b-4a6c-a5f5-be52ea98c8d9SPL set ID d6f752c5-d2bd-4f77-9611-ca2110066d1fRxCUI 2724437, 2724443UNII 0Y2S3XUQ5H
- Pharmacologic class
- Loop Diuretic
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
N484388000512followed by a unit qualifier and the quantityPackage 84388-0005-12. 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 .
Indications (excerpt from the label)
ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults. ENBUMYST is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including nephrotic syndrome in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 84388-005
- What is NDC 84388-005?
- 84388-005 is the product NDC for Enbumyst (bumetanide), Bumetanide .5 mg/.1mL spray, listed with the FDA by Corstasis USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enbumyst (Bumetanide).
- What is the active ingredient?
- Bumetanide.
- Who is the labeler?
- Corstasis USA LLC, NDC labeler code 84388. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Enbumyst?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.