Atropine
- Product NDC
- 60219-1750
- 11-digit product format
- 602191750
- Labeler code
- 60219
- Product ID
- 60219-1750_1b2b68ed-bad1-4742-b88d-1d2f0040ad52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atropine sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA214752
- Marketing category
- ANDA
- Marketing start
- 2022-07-19
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-1750-8 | Atropine | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 10 |
| 60219-1750-8 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1750 | ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240707_f8718be5-8fa4-4c36-a4fd-fac7c3953f5a.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 |
|---|
| 60219-1750-8 | 60219175008 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1750-8) / 15 mL in 1 BOTTLE, DROPPER | 2022-07-19 | 0000-00-00 | No | No | Current |