ATROPINE
- Product NDC
- 50090-7313
- 11-digit product format
- 500907313
- Labeler code
- 50090
- Product ID
- 50090-7313_db93edb4-792e-4925-9002-90978afa8cb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atropine sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ATROPINE
- Listing expiration
- 2027-12-31
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 |
|---|
| 50090-7313-0 | ATROPINE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 50090-7313-0 | ATROPINE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7313 | ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20241018_b4736dbc-b7c8-4b33-b7a8-a47c5654a127.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7313-0 | 50090731300 | 1 BOTTLE, DROPPER in 1 CARTON (50090-7313-0) / 5 mL in 1 BOTTLE, DROPPER | 2024-10-14 | No | No | Historical |