TRYPTYR
- Product NDC
- 0065-8595
- 11-digit product format
- 000658595
- Labeler code
- 0065
- Product ID
- 0065-8595_27fdd84a-2d62-4c79-afb0-5d5bd608fdfc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acoltremon
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC; TOPICAL
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA217370
- Marketing category
- NDA
- Marketing start
- 2025-07-23
- Substance
- ACOLTREMON
- Active strength
- .03 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRYPTYR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACOLTREMON | .03 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L7BVT4Z4Z |
| Rxcui | 2716821, 2716826 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0065-8595-01 | TRYPTYR | 5 in 1 POUCH | SOLUTION | 5 | | 6 |
| 0065-8595-01 | TRYPTYR | 3 in 1 CARTON | SOLUTION | 3 | | 6 |
| 0065-8595-02 | TRYPTYR | 12 in 1 CARTON | SOLUTION | 12 | | 6 |
| 0065-8595-02 | TRYPTYR | 5 in 1 POUCH | SOLUTION | 5 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0065-8595-01 | 00065859501 | 3 POUCH in 1 CARTON (0065-8595-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL | 3 pouch | 2025-07-23 | Yes | No | Historical |
| 0065-8595-02 | 00065859502 | 12 POUCH in 1 CARTON (0065-8595-02) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL | 12 pouch | 2025-07-23 | No | No | Historical |