Prescription drug · ANDA
Atropine (Atropine sulfate) NDC 68083-671
Atropine sulfate 10 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-671-01 | 68083067101 | 1 BOTTLE, DROPPER in 1 CARTON (68083-671-01) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jul 31, 2026 |
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
- Generic name (nonproprietary)
- atropine sulfate
- Active ingredients
- Atropine sulfate — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219996
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 68083-671_01f9b403-5ef9-4364-9138-7e7f65248bdeSPL ID 01f9b403-5ef9-4364-9138-7e7f65248bdeSPL set ID a116af5c-ba4c-408c-9a02-4bc33772aa8dRxCUI 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
N468083067101followed by a unit qualifier and the quantityPackage 68083-0671-01. 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 in adults and pediatric patients aged three (3) months and older for: 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia Atropine is an anti-cholinergic 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)
Excerpt only. Read the full label for complete information.
About NDC 68083-671
- What is NDC 68083-671?
- 68083-671 is the product NDC for Atropine (atropine sulfate), Atropine sulfate 10 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 | Amneal Pharmaceuticals NY LLC | 60219-1749 | 60219-1749-03 |
| 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 | 60219-1750 | 60219-1750-08 |
| 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 | Redpharm Drug | 67296-2200 | 67296-2200-05 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Apotex Corp. | 60505-6226 | 60505-6226-0060505-6226-0160505-6226-02 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7000 | 50090-7000-00 |
Other NDCs under ANDA 219996
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 | Gland Pharma Limited | 68083-669 |
| Atropineatropine sulfate | Atropine sulfate 10 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-670 |