Tropicamide
- Product NDC
- 70069-121
- 11-digit product format
- 700690121
- Labeler code
- 70069
- Product ID
- 70069-121_43c4d1f7-c795-4100-b8c1-c6fd7d0ad624
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tropicamide
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA207524
- Marketing category
- ANDA
- Marketing start
- 2019-12-12
- Substance
- TROPICAMIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tropicamide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TROPICAMIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N0A3Z5XTC6 |
| Rxcui | 314238 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-121-01 | Tropicamide | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 9 |
| 70069-121-01 | Tropicamide | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-121 | TROPICAMIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230602_378b5fe2-4b5d-4c87-a7d6-fd0caa6402af.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70069-121-01 | 70069012101 | 1 BOTTLE in 1 CARTON (70069-121-01) / 15 mL in 1 BOTTLE | 1 bottle | 2019-12-12 | 0000-00-00 | No | No | Current |