NDC codes

FDA NDC Directory
Product NDC (as listed)42677-308Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42677-0308Add 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
42677-308-01426770308011 BOTTLE, GLASS in 1 CARTON (42677-308-01) / 250 mL in 1 BOTTLE, GLASSMarketed from Aug 18, 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)
Sevoflurane
Generic name (nonproprietary)
sevoflurane
Active ingredients
Sevoflurane — 250 mL/250mL
Dosage form
Liquid
Route
Respiratory (Inhalation)
Labeler
Shandong New Time Pharmaceutical Co., Ltd.NDC labeler code 42677
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214382
Marketing start
Listing expires
Other FDA classes
General Anesthesia (Physiologic effect)
Identifiers
Product ID 42677-308_535139ad-7d0e-fbf6-e063-6394a90ab048SPL ID 535139ad-7d0e-fbf6-e063-6394a90ab048SPL set ID c808afe1-ebf1-44cf-9187-09656331bff5RxCUI 200243UNII 38LVP0K73A
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

N442677030801 followed by a unit qualifier and the quantity

Package 42677-0308-01. 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)

INDICATIONS AND USAGE Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42677-308

What is NDC 42677-308?
42677-308 is the product NDC for Sevoflurane, Sevoflurane 250 mL/250mL liquid, listed with the FDA by Shandong New Time Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sevoflurane.
What is the active ingredient?
Sevoflurane.
Who is the labeler?
Shandong New Time Pharmaceutical Co., Ltd., NDC labeler code 42677. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sevoflurane?
10 other product NDCs are listed under this name. See all Sevoflurane 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 Sevoflurane NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Lannett Company, Inc.0527-612300527-6123-74
SevofluraneSevoflurane 1 mL/mLLiquidRespiratory (Inhalation)Piramal Critical Care Inc66794-02266794-0022-25
SevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Sandoz Inc.0781-616000781-6160-86
SevofluraneSevoflurane 1 mL/mLLiquidRespiratory (Inhalation)Bryant Ranch Prepack72162-224572162-2245-02
SevofluraneSevoflurane 1 mL/mLLiquidRespiratory (Inhalation)Piramal Critical Care Inc66794-01566794-0015-25
SevofluraneSevoflurane 1 mL/mLLiquidRespiratory (Inhalation)Halocarbon Life Sciences, LLC12164-00512164-0005-25
SevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Baxter Healthcare Corporation10019-65310019-0653-64
SevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Baxter Healthcare Corporation10019-65710019-0657-06
SevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Baxter Healthcare Company10019-65110019-0651-64
SevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Baxter Healthcare Company10019-65510019-0655-06

Other NDCs under ANDA 214382

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

FDA NDC Directory listings under ANDA 214382
ProductStrengthForm · routeLabelerProduct NDC
Sevoflurane, (Volatile for Inhalation)sevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Mullan Pharmaceutical Inc.83301-0070
SevofluraneSevoflurane 250 mL/250mLLiquidRespiratory (Inhalation)Lannett Company, Inc.0527-6123

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