Prescription drug · ANDA
Isoflurane NDC 42677-327
Isoflurane 250 mL/250mL · Liquid · Respiratory (Inhalation) · Shandong New Time Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42677-327-01 | 42677032701 | 1 BOTTLE, GLASS in 1 CARTON (42677-327-01) / 250 mL in 1 BOTTLE, GLASSMarketed from Nov 4, 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)
- Isoflurane
- Generic name (nonproprietary)
- isoflurane
- Active ingredients
- Isoflurane — 250 mL/250mL
- Dosage form
- Liquid
- Route
- Respiratory (Inhalation)
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216527
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 42677-327_47b13264-ce08-a7fd-e063-6394a90ad6ebSPL ID 47b13264-ce08-a7fd-e063-6394a90ad6ebSPL set ID 662ceaf6-650b-4dea-bbee-652f46426024RxCUI 542347UNII CYS9AKD70P
- 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
N442677032701followed by a unit qualifier and the quantityPackage 42677-0327-01. 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 .
Indications (excerpt from the label)
Isoflurane, USP liquid for inhalation 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 liquid for inhalation, 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 216527
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 |
|---|---|---|---|---|
| Isoflurane, (Volatile for Inhalation)isoflurane | Isoflurane 250 mL/250mL | LiquidRespiratory (Inhalation) | Mullan Pharmaceutical Inc. | 83301-0072 |
| Isoflurane, (Volatile for Inhalation)isoflurane | Isoflurane 100 mL/100mL | LiquidRespiratory (Inhalation) | Mullan Pharmaceutical Inc. | 83301-0071 |
| Isoflurane | Isoflurane 100 mL/100mL | LiquidRespiratory (Inhalation) | Shandong New Time Pharmaceutical Co., Ltd. | 42677-326 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.