Over-the-counter drug · ANDA

Naloxone Hydrochloride NDC 0480-3478

Naloxone hydrochloride 4 mg/.1mL · Spray, Metered · Nasal · Teva Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0480-3478Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00480-3478Add 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
0480-3478-68004803478682 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 23, 2024

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 — 4 mg/.1mL
Dosage form
Spray, Metered
Route
Nasal
Labeler
Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209522
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 0480-3478_7545d296-ad3c-4be1-9913-73b4f870e90cSPL ID 7545d296-ad3c-4be1-9913-73b4f870e90cSPL set ID 3a73ee4b-c2a4-496f-be90-9f78c8046062RxCUI 1725059UNII 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400480347868 followed by a unit qualifier and the quantity

Package 00480-3478-68. 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)

Uses to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-3478

What is NDC 0480-3478?
0480-3478 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 4 mg/.1mL spray, metered, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naloxone Hydrochloride.
What is the active ingredient?
Naloxone hydrochloride.
Who is the labeler?
Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naloxone Hydrochloride?
77 other product NDCs are listed under this name. See all Naloxone Hydrochloride 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 Naloxone Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
naloxone hydrochlorideNaloxone hydrochloride .4 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousLifestar Pharma LLC70756-85070756-0850-1070756-0850-2570756-0850-82
Naloxone HydrochlorideNaloxone hydrochloride .4 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHenry Schein, Inc.0404-977300404-9773-01
Naloxone HydrochlorideNaloxone hydrochloride .4 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-619300641-6193-10
naloxone hydrochlorideNaloxone hydrochloride 1 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousBaxter Healthcare Corporation43066-14243066-0142-10
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalBluePoint Laboratories68001-64568001-0645-45
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalStrategic Sourcing Services LLC70677-128370677-1283-01
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalAMERISOURCE BERGEN46122-81246122-0812-71
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalActavis Pharma, Inc.0591-387100591-3871-99
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousPar Health USA, LLC42023-22442023-0224-01
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalAsclemed USA, Inc.76420-86776420-0867-02

All 78 Naloxone Hydrochloride NDCs

Other NDCs under ANDA 209522

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

FDA NDC Directory listings under ANDA 209522
ProductStrengthForm · routeLabelerProduct NDC
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalActavis Pharma, Inc.0591-3871
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalAsclemed USA, Inc.76420-867
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalSportpharm LLC85766-228

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