Prescription drug · NDA
Atropine Injection, 2 mg NDC 71053-592
Atropine 2 mg/.7mL · Injection · Intramuscular · Rafa Laboratories, Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71053-592-01 | 71053059201 | 480 CARTON in 1 BOX (71053-592-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGEMarketed from Jul 9, 2018 |
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
- Generic name (nonproprietary)
- atropine injection, 2 mg
- Active ingredients
- Atropine — 2 mg/.7mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Rafa Laboratories, Ltd.NDC labeler code 71053
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212319
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 71053-592_4b1cda4c-c117-7a42-e063-6294a90a14e2SPL ID 4b1cda4c-c117-7a42-e063-6294a90a14e2SPL set ID 4a4fa6e8-0e0a-0e76-e054-00144ff8d46cRxCUI 1190538, 1190540, 1190542UNII 7C0697DR9IUPC 0371053591013, 0371053590016
- 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.
- NDC on a medical claim
N471053059201followed by a unit qualifier and the quantityPackage 71053-0592-01. 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 the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). Atropine, a cholinergic muscarinic antagonist, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds) (1).
Excerpt only. Read the full label for complete information.
About NDC 71053-592
- What is NDC 71053-592?
- 71053-592 is the product NDC for Atropine Injection, 2 mg, Atropine 2 mg/.7mL injection, listed with the FDA by Rafa Laboratories, Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atropine Injection, 2 mg.
- What is the active ingredient?
- Atropine.
- Who is the labeler?
- Rafa Laboratories, Ltd., NDC labeler code 71053. 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 Injection, 2 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.