Tropicamide
- Product NDC
- 61314-355
- 11-digit product format
- 613140355
- Labeler code
- 61314
- Product ID
- 61314-355_51620df4-8e34-4ffa-bf5a-077efc3a1911
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tropicamide
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA084306
- Marketing category
- ANDA
- Marketing start
- 2000-06-13
- Substance
- TROPICAMIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tropicamide
- Listing expiration
- 2026-12-31
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 |
|---|
| 61314-355-01 | Tropicamide | 3 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 3 | | 5 |
| 61314-355-01 | Tropicamide | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
| 61314-355-02 | Tropicamide | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
| 61314-355-02 | Tropicamide | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-355 | TROPICAMIDE SOLUTION/ DROPS [SANDOZ INC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20220702_0104ffe4-013d-4afa-996d-dcba4f08e93d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61314-355-01 | 61314035501 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-355-01) / 3 mL in 1 BOTTLE, PLASTIC | 2000-06-13 | 0000-00-00 | No | No | Current |
| 61314-355-02 | 61314035502 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-355-02) / 15 mL in 1 BOTTLE, PLASTIC | 2000-06-13 | 0000-00-00 | No | No | Current |