Prescription drug · ANDA
Tropicamide NDC 70069-121
Tropicamide 10 mg/mL · Solution/ drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-121-01 | 7006901210170069012101 | 1 BOTTLE in 1 CARTON (70069-121-01) / 15 mL in 1 BOTTLEMarketed from Dec 12, 2019 |
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)
- Tropicamide
- Generic name (nonproprietary)
- tropicamide
- Active ingredients
- Tropicamide — 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 207524
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 70069-121_43c4d1f7-c795-4100-b8c1-c6fd7d0ad624SPL ID 43c4d1f7-c795-4100-b8c1-c6fd7d0ad624SPL set ID 378b5fe2-4b5d-4c87-a7d6-fd0caa6402afRxCUI 314238UNII N0A3Z5XTC6UPC 0370069121016
- Pharmacologic class
- Anticholinergic
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
N470069012101followed by a unit qualifier and the quantityPackage 70069-0121-01. 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)
INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.
Excerpt only. Read the full label for complete information.
About NDC 70069-121
- What is NDC 70069-121?
- 70069-121 is the product NDC for Tropicamide, Tropicamide 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?
- Tropicamide.
- What is the active ingredient?
- Tropicamide.
- 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 Tropicamide?
- 7 other product NDCs are listed under this name. See all Tropicamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tropicamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-040 | 85766-0040-15 |
| Tropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 61314-355 | 61314-0355-0161314-0355-02 |
| Tropicamide | Tropicamide 5 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 61314-354 | 61314-0354-01 |
| Tropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-585 | 24208-0585-5924208-0585-64 |
| Tropicamide | Tropicamide 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-590 | 24208-0590-64 |
| Tropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-278 | 85766-0278-15 |
| Tropicamide | Tropicamide 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-279 | 85766-0279-15 |
Other NDCs under ANDA 207524
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 |
|---|---|---|---|---|
| Tropicamide | Tropicamide 10 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-040 |