NDC codes

FDA NDC Directory
Product NDC (as listed)0404-9922Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-9922Add 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
0404-9922-02004049922021 SYRINGE in 1 BAG (0404-9922-02) / 2 mL in 1 SYRINGEMarketed from Jan 13, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Naloxone Hydrochloride
Generic name (nonproprietary)
naloxone hydrochloride
Active ingredients
Naloxone hydrochloride — 1 mg/mL
Dosage form
Injection
Route
Parenteral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072076
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 0404-9922_ace20fdd-3422-48d9-acf4-da37f78f13a7SPL ID ace20fdd-3422-48d9-acf4-da37f78f13a7SPL set ID bd65e3fe-cd7a-4855-8f55-8cc3a0921cccRxCUI 1191250UNII F850569PQR
Pharmacologic class
Opioid Antagonist

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

N400404992202 followed by a unit qualifier and the quantity

Package 00404-9922-02. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 072076

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

FDA NDC Directory listings under ANDA 072076
ProductStrengthForm · routeLabelerProduct NDC
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionParenteralInternational Medication Systems, Limited76329-1469
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionParenteralInternational Medication Systems, Limited76329-3369
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionParenteralInternational Medication Systems, Limited76329-3469
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionParenteralMedical Purchasing Solutions, LLC71872-7177
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionParenteralHF Acquisition Co. LLC, DBA HealthFirst51662-1239
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionParenteralMedical Purchasing Solutions, LLC71872-7294
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionParenteralREMEDYREPACK INC.70518-2725

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