Atropine Sulfate NDC 16729-512

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0512Add 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
16729-512-43	16729051243	10 CARTON in 1 BOX (16729-512-43) / 1 VIAL, MULTI-DOSE in 1 CARTON (16729-512-05) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 25, 2021

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): 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: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213424
Marketing start: Mar 25, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 16729-512_275def6c-5b2d-918b-e063-6294a90aa71fSPL ID 275def6c-5b2d-918b-e063-6294a90aa71fSPL set ID f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c7RxCUI 1190776UNII 03J5ZE7KA5UPC 0316729512053
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

N416729051243 followed by a unit qualifier and the quantity

Package 16729-0512-43. 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 Nov 20, 2024.

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)