Prescription drug · ANDA
Isoflurane NDC 66794-020
Isoflurane 1 mL/mL · Liquid · Respiratory (Inhalation) · Piramal Critical Care, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-020-10 | 66794002010 | 100 mL in 1 BOTTLE (66794-020-10)Marketed from Nov 13, 2013 | |
| 66794-020-25 | 66794002025 | 250 mL in 1 BOTTLE, GLASS (66794-020-25)Marketed from Nov 13, 2013 |
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)
- Isoflurane
- Generic name (nonproprietary)
- isoflurane
- Active ingredients
- Isoflurane — 1 mL/mL
- Dosage form
- Liquid
- Route
- Respiratory (Inhalation)
- Labeler
- Piramal Critical Care, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074416
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 66794-020_43ec760c-2344-b345-e063-6394a90a6293SPL ID 43ec760c-2344-b345-e063-6394a90a6293SPL set ID 13c9c37a-0c3d-450a-a61e-d2796818b18fRxCUI 542347UNII CYS9AKD70PUPC 0366794020106
- Pharmacologic class
- General Anesthetic
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.
- NDC on a medical claim
N466794002010followed by a unit qualifier and the quantityPackage 66794-0020-10. 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)
Isoflurane USP may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Isoflurane USP, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074416
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 |
|---|---|---|---|---|
| Terrellisoflurane | Isoflurane 1 mL/mL | LiquidRespiratory (Inhalation) | Piramal Critical Care, Inc. | 66794-011 |