NDC codes

FDA NDC Directory
Product NDC (as listed)66794-017Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66794-0017Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
66794-017-106679400171066794001710100 mL in 1 BOTTLE, GLASS (66794-017-10)Marketed from Oct 7, 2011
66794-017-256679400172566794001725250 mL in 1 BOTTLE, GLASS (66794-017-25)Marketed from Oct 7, 2011

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.NDC labeler code 66794
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074502
Marketing start
Listing expires
Other FDA classes
General Anesthesia (Physiologic effect)
Identifiers
Product ID 66794-017_2a79d440-2b83-c291-e063-6294a90a55c9SPL ID 2a79d440-2b83-c291-e063-6294a90a55c9SPL set ID d6851c71-0c2f-43f6-883c-a43fe894985dRxCUI 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

N466794001710 followed by a unit qualifier and the quantity

Package 66794-0017-10. 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.

Full label on DailyMed (opens in a new tab)

About NDC 66794-017

What is NDC 66794-017?
66794-017 is the product NDC for Isoflurane, Isoflurane 1 mL/mL liquid, listed with the FDA by Piramal Critical Care, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Isoflurane.
What is the active ingredient?
Isoflurane.
Who is the labeler?
Piramal Critical Care, Inc., NDC labeler code 66794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isoflurane?
4 other product NDCs are listed under this name. See all Isoflurane NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Isoflurane NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IsofluraneIsoflurane 100 mL/100mLLiquidRespiratory (Inhalation)Shandong New Time Pharmaceutical Co., Ltd.42677-32642677-0326-01
IsofluraneIsoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Shandong New Time Pharmaceutical Co., Ltd.42677-32742677-0327-01
IsofluraneIsoflurane 1 mL/mLLiquidRespiratory (Inhalation)Piramal Critical Care, Inc.66794-02066794-0020-1066794-0020-25
IsofluraneIsoflurane 1 mL/mLLiquidRespiratory (Inhalation)Halocarbon Life Sciences, LLC12164-01212164-0012-1012164-0012-25

Other NDCs under ANDA 074502

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074502
ProductStrengthForm · routeLabelerProduct NDC
TerrellisofluraneIsoflurane 1 mL/mLLiquidRespiratory (Inhalation)Piramal Critical Care Inc66794-019

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