NDC codes

FDA NDC Directory
Product NDC (as listed)0404-9804Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-9804Add 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
0404-9804-2000404980420004049804201 VIAL, MULTI-DOSE in 1 BAG (0404-9804-20) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 1, 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)
Atropine Sulfate
Generic name (nonproprietary)
atropine sulfate
Active ingredients
Atropine sulfate — .4 mg/mL
Dosage form
Injection, Solution
Route
Endotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous
Labeler
Henry Schein, Inc.NDC labeler code 0404
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 209260
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 0404-9804_f146f48d-bd05-46f2-ad39-b930a05ea158SPL ID f146f48d-bd05-46f2-ad39-b930a05ea158SPL set ID 6acb3f07-9e32-4ad0-8336-e2f33d55b127RxCUI 1190776UNII 03J5ZE7KA5
Pharmacologic class
Anticholinergic; Cholinergic Muscarinic 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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400404980420 followed by a unit qualifier and the quantity

Package 00404-9804-20. 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)

Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia. Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0404-9804

What is NDC 0404-9804?
0404-9804 is the product NDC for Atropine Sulfate, Atropine sulfate .4 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Atropine Sulfate.
What is the active ingredient?
Atropine sulfate.
Who is the labeler?
Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Atropine Sulfate?
61 other product NDCs are listed under this name. See all Atropine Sulfate 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 Atropine Sulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Atropine sulfateAtropine sulfate 10 mg/mLSolution/ dropsOphthalmicEdenbridge Pharmaceuticals LLC.42799-82642799-0826-0142799-0826-0242799-0826-03
Atropine SulfateAtropine sulfate .4 mg/mLInjectionIntravascularHikma Pharmaceuticals USA Inc.0641-627400641-6274-25
Atropine SulfateAtropine sulfate 1 mg/mLInjectionIntravenousHikma Pharmaceuticals USA Inc.0641-627500641-6275-25
Atropine SulfateAtropine sulfate .1 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-978400404-9784-05
Atropine SulfateAtropine sulfate .4 mg/mLInjectionEndotracheal, Intramedullary, Intramuscular, Intravenous, SubcutaneousREMEDYREPACK INC.70518-432970518-4329-00
Atropine sulfateAtropine sulfate 10 mg/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-58370069-0583-01
Atropine Sulfateatropine sulfate monohydrateAtropine sulfate .4 mg/mLSolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, SubcutaneousMedical Purchasing Solutions, LLC71872-735571872-7355-01
Atropine Sulfateatropine sulfate monohydrateAtropine sulfate .4 mg/mLSolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, SubcutaneousSomerset Therapeutics, LLC70069-48170069-0481-10
Atropine SulfateAtropine sulfate .4 mg/mLInjection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, SubcutaneousREMEDYREPACK INC.70518-418870518-4188-00
Atropine SulfateAtropine sulfate 10 mg/mLSolution/ dropsOphthalmicNorthStar RxLLC72603-26472603-0264-0172603-0264-02

All 62 Atropine Sulfate NDCs

Other NDCs under NDA 209260

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

FDA NDC Directory listings under NDA 209260
ProductStrengthForm · routeLabelerProduct NDC
Atropine SulfateAtropine sulfate .4 mg/mLInjection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, SubcutaneousFresenius Kabi USA, LLC63323-580
Atropine SulfateAtropine sulfate .4 mg/mLInjection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, SubcutaneousREMEDYREPACK INC.70518-4188
Atropine SulfateAtropine sulfate .4 mg/mLInjection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, SubcutaneousProPharma Distribution84549-580

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