atropine sulfate
- Product NDC
- 70121-1706
- 11-digit product format
- 701211706
- Labeler code
- 70121
- Product ID
- 70121-1706_cd6e7dcc-16d0-4663-859e-c22fe300a536
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atropine sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA215342
- Marketing category
- ANDA
- Marketing start
- 2024-01-09
- 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 | 1190546, 1190552 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70121-1706-1 | atropine sulfate | 10 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 10 | | 12 |
| 70121-1706-1 | atropine sulfate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 12 |
| 70121-1706-2 | atropine sulfate | 5 in 1 TRAY | INJECTION, SOLUTION | 5 | | 12 |
| 70121-1706-2 | atropine sulfate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 12 |
| 70121-1706-4 | atropine sulfate | 24 in 1 PACKAGE | INJECTION, SOLUTION | 24 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-1706 | ATROPINE SULFATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 10 | Current NDC, 5 package rows | 20240920_80a31286-a741-4440-b200-290c08925d06.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 |
|---|
| 70121-1706-1 | 70121170601 | 10 mL in 1 SYRINGE, GLASS | 10 ml | | | | Historical |
| 70121-1706-2 | 70121170602 | 10 TRAY in 1 CARTON (70121-1706-2) / 5 SYRINGE, GLASS in 1 TRAY / 10 mL in 1 SYRINGE, GLASS | 10 tray | 2024-01-09 | No | No | Historical |
| 70121-1706-4 | 70121170604 | 24 CARTON in 1 PACKAGE (70121-1706-4) / 1 SYRINGE, GLASS in 1 CARTON (70121-1706-1) / 10 mL in 1 SYRINGE, GLASS | 24 carton | 2024-09-18 | No | No | Historical |