ATROPINE SULFATE
- Product NDC
- 51662-1626
- 11-digit product format
- 516621626
- Labeler code
- 51662
- Product ID
- 51662-1626_100be173-227f-a802-e063-6294a90ae92e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATROPINE SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA216120
- Marketing category
- ANDA
- Marketing start
- 2023-07-13
- Substance
- ATROPINE SULFATE
- Active strength
- 1 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 SULFATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPINE SULFATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190795 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1626-1 | ATROPINE SULFATE | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1626-2 | ATROPINE SULFATE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1626-3 | ATROPINE SULFATE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1626 | ATROPINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, 3 package rows | 20240130_0060b971-19bd-2849-e063-6294a90afca8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51662-1626-1 | 51662162601 | 1 mL in 1 VIAL, GLASS | 1 ml | | | | Historical |
| 51662-1626-2 | 51662162602 | 1 in 1 POUCH | | | | | Historical |
| 51662-1626-3 | 51662162603 | 25 POUCH in 1 CASE (51662-1626-3) / 1 VIAL, GLASS in 1 POUCH (51662-1626-2) / 1 mL in 1 VIAL, GLASS (51662-1626-1) | 25 pouch | 2023-10-02 | No | No | Current |