Prescription drug · ANDA
Atropine (Atropine sulfate) NDC 67296-2200
Atropine sulfate 10 mg/mL · Solution/ drops · Ophthalmic · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2200-5 | 6729622000567296220005 | 1 BOTTLE, DROPPER in 1 CARTON (67296-2200-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 26, 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
- Generic name (nonproprietary)
- atropine sulfate
- Active ingredients
- Atropine sulfate — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215624
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 67296-2200_46e98d4d-db38-11f2-e063-6294a90a7e7cSPL ID 46e98d4d-db38-11f2-e063-6294a90a7e7cSPL set ID 46e98d0b-3a04-7feb-e063-6394a90ac75eRxCUI 1190655UNII 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 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
N467296220005followed by a unit qualifier and the quantityPackage 67296-2200-05. 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)
1. INDICATIONS AND USAGE Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for: Atropine is an anticholinergic agent indicated in adults and pediatric patients aged three (3) months and older 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 67296-2200
- What is NDC 67296-2200?
- 67296-2200 is the product NDC for Atropine (atropine sulfate), Atropine sulfate 10 mg/mL solution/ drops, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atropine (Atropine Sulfate).
- What is the active ingredient?
- Atropine sulfate.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. 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?
- 9 other product NDCs are listed under this name. See all Atropine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atropine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-669 | 68083-0669-01 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-670 | 68083-0670-01 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-671 | 68083-0671-01 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7313 | 50090-7313-00 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1748 | 60219-1748-02 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1749 | 60219-1749-03 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-1750 | 60219-1750-08 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7000 | 50090-7000-00 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Apotex Corp. | 60505-6226 | 60505-6226-0060505-6226-0160505-6226-02 |
Other NDCs under ANDA 215624
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 |
|---|---|---|---|---|
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7000 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Apotex Corp. | 60505-6226 |