Prescription drug · ANDA
Furosemide NDC 42571-438
Furosemide 100 mg/10mL · Injection · Intramuscular, Intravenous · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-438-85 | 4257104388542571043885 | 25 VIAL in 1 CARTON (42571-438-85) / 10 mL in 1 VIAL (42571-438-56)Marketed from Nov 16, 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)
- Furosemide
- Generic name (nonproprietary)
- furosemide
- Active ingredients
- Furosemide — 100 mg/10mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218188
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 42571-438_4829e889-87d2-9d87-e063-6294a90a11cbSPL ID 4829e889-87d2-9d87-e063-6294a90a11cbSPL set ID 2f547f7c-0322-465c-9764-43f955d98ab2RxCUI 1719286, 1719290, 1719291UNII 7LXU5N7ZO5UPC 0342571437862, 0342571438562, 0342571436759
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N442571043885followed by a unit qualifier and the quantityPackage 42571-0438-85. 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 Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impai…
Excerpt only. Read the full label for complete information.
About NDC 42571-438
- What is NDC 42571-438?
- 42571-438 is the product NDC for Furosemide, Furosemide 100 mg/10mL injection, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Furosemide.
- What is the active ingredient?
- Furosemide.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Furosemide?
- 204 other product NDCs are listed under this name. See all Furosemide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Furosemide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Furosemide | Furosemide 10 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-275 | 72572-0275-10 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4679 | 70518-4679-00 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-033 | 87441-0033-01 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Coupler LLC | 67046-0768 | 67046-0768-03 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4609 | 70518-4609-00 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | Coupler LLC | 67046-1663 | 67046-1663-03 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-832 | 10135-0832-0110135-0832-1010135-0832-90 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-833 | 10135-0833-0110135-0833-1010135-0833-90 |
| Furosemide | Furosemide 80 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-834 | 10135-0834-0110135-0834-0510135-0834-90 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Granulation Technology, Inc. | 63561-0164 | 63561-0164-0163561-0164-0263561-0164-09 |
Other NDCs under ANDA 218188
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 |
|---|---|---|---|---|
| Furosemide | Furosemide 20 mg/2mL | InjectionIntramuscular, Intravenous | Micro Labs Limited | 42571-436 |
| Furosemide | Furosemide 40 mg/4mL | InjectionIntramuscular, Intravenous | Micro Labs Limited | 42571-437 |