Prescription drug · ANDA
Atropine Sulfate NDC 0641-6274
Atropine sulfate .4 mg/mL · Injection · Intravascular · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6274-25 | 0064162742500641627425 | 25 VIAL in 1 CARTON (0641-6274-25) / 1 mL in 1 VIAL (0641-6274-01)Marketed from Nov 7, 2025 |
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
- Route
- Intravascular
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217345
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0641-6274_4298dd9c-15f7-4bab-be40-c0250eb01886SPL ID 4298dd9c-15f7-4bab-be40-c0250eb01886SPL set ID a66eecf9-2d8b-4e2d-8a05-d718dcbc3542RxCUI 1190795, 1666781UNII 03J5ZE7KA5UPC 0306416275255
- 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.
- NDC on a medical claim
N400641627425followed by a unit qualifier and the quantityPackage 00641-6274-25. 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 .
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. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0641-6274
- What is NDC 0641-6274?
- 0641-6274 is the product NDC for Atropine Sulfate, Atropine sulfate .4 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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 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 |
| Atropine Sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | NorthStar RxLLC | 72603-264 | 72603-0264-0172603-0264-02 |
Other NDCs under ANDA 217345
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 | Hikma Pharmaceuticals USA Inc. | 0641-6275 |