Prescription drug · ANDA
Atropine sulfate NDC 70069-582
Atropine sulfate 10 mg/mL · Solution/ drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-582-01 | 7006905820170069058201 | 1 BOTTLE in 1 CARTON (70069-582-01) / 5 mL in 1 BOTTLEMarketed from Jul 4, 2024 |
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 — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215618
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 70069-582_43d3dd59-36b1-493f-86a3-c5eee9750ee8SPL ID 43d3dd59-36b1-493f-86a3-c5eee9750ee8SPL set ID e30491ed-938e-4ef4-aa23-a2e94cbab0edRxCUI 1190655UNII 03J5ZE7KA5UPC 0370069582015, 0370069583012, 0370069581018
- 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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470069058201followed by a unit qualifier and the quantityPackage 70069-0582-01. 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 ophthalmic solution, 1% is indicated for: Atropine is an anti-muscarinic agent indicated for: Cycloplegia (1.1) Mydriasis (1.2) Penalization of the healthy eye in the treatment of amblyopia (1.3) 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the healthy eye in the treatment of amblyopia
Excerpt only. Read the full label for complete information.
About NDC 70069-582
- What is NDC 70069-582?
- 70069-582 is the product NDC for Atropine sulfate, Atropine sulfate 10 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. 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?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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 215618
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 10 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-581 |
| Atropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-583 |