Prescription drug · ANDA
Atropine Sulfate NDC 76329-3340
Atropine sulfate .1 mg/mL · Injection · Intravenous · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-3340-1 | 7632933400176329334001 | 10 CARTON in 1 PACKAGE (76329-3340-1) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGEMarketed from Feb 17, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — .1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- International Medication Systems, LimitedNDC labeler code 76329
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212461
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 76329-3340_697aa53c-f31f-463a-a752-d2faaad354dbSPL ID 697aa53c-f31f-463a-a752-d2faaad354dbSPL set ID b72d0a82-6163-460f-965a-12f6da47370aRxCUI 1190546UNII 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.
- NDC on a medical claim
N476329334001followed by a unit qualifier and the quantityPackage 76329-3340-01. 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 Sulfate Injection 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.
Excerpt only. Read the full label for complete information.
About NDC 76329-3340
- What is NDC 76329-3340?
- 76329-3340 is the product NDC for Atropine Sulfate, Atropine sulfate .1 mg/mL injection, listed with the FDA by International Medication Systems, Limited. 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?
- International Medication Systems, Limited, NDC labeler code 76329. 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.
Related NDCs: other Atropine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 212461
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Atropine Sulfate | Atropine sulfate .1 mg/mL | InjectionIntravenous | A-S Medication Solutions | 50090-5924 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1527 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | InjectionIntravenous | REMEDYREPACK INC. | 70518-3120 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7252 |
| Atropine Sulfate | Atropine sulfate .1 mg/mL | InjectionIntravenous | ProPharma Distribution | 84549-340 |