Isopto Atropine
- Product NDC
- 0065-0303
- 11-digit product format
- 000650303
- Labeler code
- 0065
- Product ID
- 0065-0303_b3493429-e973-4c38-8e7b-23376075bd20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atropine sulfate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA208151
- Marketing category
- NDA
- Marketing start
- 2018-08-01
- Substance
- ATROPINE SULFATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic 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
- Isopto Atropine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPINE SULFATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190655, 1190664 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0065-0303-55 | Isopto Atropine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 8 |
| 0065-0303-55 | Isopto Atropine | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0303 | ISOPTO ATROPINE (ATROPINE SULFATE) SOLUTION [ALCON LABORATORIES, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20221012_20491566-e6eb-8d4a-3083-77ea429f7bc4.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 |
|---|
| 0065-0303-15 | 00065030315 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0303-15) > 15 mL in 1 BOTTLE, DROPPER | 2016-12-09 | 0000-00-00 | No | No | Current |
| 0065-0303-55 | 00065030355 | 1 BOTTLE, DROPPER in 1 CARTON (0065-0303-55) > 5 mL in 1 BOTTLE, DROPPER | 2016-12-09 | 0000-00-00 | No | No | Current |