Atropine Sulfate
- Product NDC
- 16729-512
- 11-digit product format
- 167290512
- Labeler code
- 16729
- Product ID
- 16729-512_275def6c-5b2d-918b-e063-6294a90aa71f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA213424
- Marketing category
- ANDA
- Marketing start
- 2021-03-25
- 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 |
|---|
| 16729-512-05 | Atropine Sulfate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 16729-512-05 | Atropine Sulfate | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 4 |
| 16729-512-43 | Atropine Sulfate | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-512 | ATROPINE SULFATE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20241122_f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c7.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 |
|---|
| 16729-512-05 | 16729051205 | 1 in 1 CARTON | | | | | | Historical |
| 16729-512-43 | 16729051243 | 10 CARTON in 1 BOX (16729-512-43) / 1 VIAL, MULTI-DOSE in 1 CARTON (16729-512-05) / 20 mL in 1 VIAL, MULTI-DOSE | 10 carton | 2021-03-25 | 0000-00-00 | No | No | Current |