ATROPINE SULFATE
- Product NDC
- 51662-1619
- 11-digit product format
- 516621619
- Labeler code
- 51662
- Product ID
- 51662-1619_100d196c-c853-3cf7-e063-6294a90ad8c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATROPINE SULFATE
- Dosage form
- INJECTION
- Route
- ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA213561
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- Substance
- ATROPINE SULFATE
- Active strength
- .4 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 | .4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190776 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1619-1 | ATROPINE SULFATE | 20 mL in 1 VIAL | INJECTION | 20 | | 4 |
| 51662-1619-2 | ATROPINE SULFATE | 20 mL in 1 VIAL | INJECTION | 20 | | 4 |
| 51662-1619-2 | ATROPINE SULFATE | 1 in 1 POUCH | INJECTION | 1 | | 4 |
| 51662-1619-3 | ATROPINE SULFATE | 10 in 1 CASE | INJECTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1619 | ATROPINE SULFATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240130_e9fd624a-9abd-dfea-e053-2a95a90a8e9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1619-1 | 51662161901 | 20 mL in 1 VIAL (51662-1619-1) | 20 ml | 2022-11-10 | 0000-00-00 | No | No | Current |
| 51662-1619-2 | 51662161902 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |
| 51662-1619-3 | 51662161903 | 10 POUCH in 1 CASE (51662-1619-3) / 1 VIAL in 1 POUCH (51662-1619-2) / 20 mL in 1 VIAL | 10 pouch | 2022-10-01 | 0000-00-00 | No | No | Current |