Atropine
- Product NDC
- 60505-6226
- 11-digit product format
- 605056226
- Labeler code
- 60505
- Product ID
- 60505-6226_b7f34028-c9e4-4505-1395-1e65fd56e27f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA215624
- Marketing category
- ANDA
- Marketing start
- 2021-11-26
- 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 |
|---|
| 60505-6226-0 | Atropine | 2 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2 | | 8 |
| 60505-6226-0 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 8 |
| 60505-6226-1 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 8 |
| 60505-6226-1 | Atropine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 8 |
| 60505-6226-2 | Atropine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 8 |
| 60505-6226-2 | Atropine | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6226 | ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [APOTEX CORP.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240920_127a7e32-a150-01d6-a66a-b7708d85809f.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 |
|---|
| 60505-6226-0 | 60505622600 | 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0) / 2 mL in 1 BOTTLE, DROPPER | 2021-11-26 | 0000-00-00 | No | No | Current |
| 60505-6226-1 | 60505622601 | 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-1) / 5 mL in 1 BOTTLE, DROPPER | 2021-11-26 | 0000-00-00 | No | No | Current |
| 60505-6226-2 | 60505622602 | 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-2) / 15 mL in 1 BOTTLE, DROPPER | 2022-02-07 | 0000-00-00 | No | No | Current |