What is NDC 0517-1004?

0517-1004 is the product NDC for Atropine Sulfate, Atropine sulfate .4 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

American Regent, Inc., NDC labeler code 0517. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atropine Sulfate NDC 0517-1004 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-1004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-1004Add 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 NDC	11-digit (billing)	Package	Copy
0517-1004-25	0051710042500517100425	25 VIAL, GLASS in 1 TRAY (0517-1004-25) / 1 mL in 1 VIAL, GLASS (0517-1004-01)Marketed from Aug 2, 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): Atropine Sulfate
Generic name (nonproprietary): atropine sulfate
Active ingredients: Atropine sulfate — .4 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: American Regent, Inc.NDC labeler code 0517
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216120
Marketing start: Aug 2, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0517-1004_1c500ed9-94a9-472c-bfb7-50e1fcfc31fbSPL ID 1c500ed9-94a9-472c-bfb7-50e1fcfc31fbSPL set ID 6fee1727-52b7-4f73-ab45-ef47d6a1c5bbRxCUI 1190795, 1666781UNII 03J5ZE7KA5UPC 0305171004254, 0305171001253
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

N400517100425 followed by a unit qualifier and the quantity

Package 00517-1004-25. 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 Sep 1, 2021.

Indications (excerpt from the label)

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. 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 0517-1004

What is NDC 0517-1004?: 0517-1004 is the product NDC for Atropine Sulfate, Atropine sulfate .4 mg/mL injection, solution, listed with the FDA by American Regent, 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?: American Regent, Inc., NDC labeler code 0517. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Atropine sulfate	Atropine sulfate 10 mg/mL	Solution/ dropsOphthalmic	Edenbridge Pharmaceuticals LLC.	42799-826	42799-0826-0142799-0826-0242799-0826-03
Atropine Sulfate	Atropine sulfate .4 mg/mL	InjectionIntravascular	Hikma Pharmaceuticals USA Inc.	0641-6274	00641-6274-25
Atropine Sulfate	Atropine sulfate 1 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6275	00641-6275-25
Atropine Sulfate	Atropine sulfate .1 mg/mL	Injection, SolutionIntravenous	Henry Schein, Inc.	0404-9784	00404-9784-05
Atropine Sulfate	Atropine sulfate .4 mg/mL	InjectionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	REMEDYREPACK INC.	70518-4329	70518-4329-00
Atropine sulfate	Atropine sulfate 10 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-583	70069-0583-01
Atropine Sulfateatropine sulfate monohydrate	Atropine sulfate .4 mg/mL	SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	Medical Purchasing Solutions, LLC	71872-7355	71872-7355-01
Atropine Sulfateatropine sulfate monohydrate	Atropine sulfate .4 mg/mL	SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	Somerset Therapeutics, LLC	70069-481	70069-0481-10
Atropine Sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	Henry Schein, Inc.	0404-9804	00404-9804-20
Atropine Sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	REMEDYREPACK INC.	70518-4188	70518-4188-00

All 62 Atropine Sulfate NDCs

Other NDCs under ANDA 216120

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

FDA NDC Directory listings under ANDA 216120
Product	Strength	Form · route	Labeler	Product NDC
Atropine Sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionIntravenous	Henry Schein, Inc	0404-9802
Atropine Sulfate	Atropine sulfate 1 mg/mL	Injection, SolutionIntravenous	American Regent, Inc.	0517-1001
Atropine Sulfate	Atropine sulfate 1 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1626
Atropine sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1627
Atropine Sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7312
Atropine Sulfate	Atropine sulfate 1 mg/mL	Injection, SolutionIntravenous	ProPharma Distribution	84549-001