ATROPINE SULFATE
- Product NDC
- 16729-484
- 11-digit product format
- 167290484
- Labeler code
- 16729
- Product ID
- 16729-484_4082a1cf-1e1b-6f40-e063-6294a90aec06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATROPINE SULFATE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare, Inc.,
- Application
- ANDA212868
- Marketing category
- ANDA
- Marketing start
- 2021-07-30
- 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, 1190551, 1190552 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-484-03 | ATROPINE SULFATE | 10 mL in 1 SYRINGE, GLASS | INJECTION | 10 | | 9 |
| 16729-484-31 | ATROPINE SULFATE | 5 mL in 1 SYRINGE, GLASS | INJECTION | 5 | | 9 |
| 16729-484-45 | ATROPINE SULFATE | 10 mL in 1 SYRINGE, GLASS | INJECTION | 10 | | 9 |
| 16729-484-45 | ATROPINE SULFATE | 10 in 1 CARTON | INJECTION | 10 | | 9 |
| 16729-484-90 | ATROPINE SULFATE | 10 in 1 CARTON | INJECTION | 10 | | 9 |
| 16729-484-90 | ATROPINE SULFATE | 5 mL in 1 SYRINGE, GLASS | INJECTION | 5 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-484 | ATROPINE SULFATE INJECTION [ACCORD HEALTHCARE, INC.,] | 8 | Current NDC, Legacy NDC, 6 package rows | 20241122_c82cb295-ffce-47d6-97ad-a8aa723f4e4f.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 |
|---|
| 16729-484-03 | 16729048403 | 10 mL in 1 SYRINGE, GLASS (16729-484-03) | 10 ml | 2021-07-30 | 0000-00-00 | No | No | Current |
| 16729-484-31 | 16729048431 | 5 mL in 1 SYRINGE, GLASS (16729-484-31) | 5 ml | 2021-07-30 | 0000-00-00 | No | No | Current |
| 16729-484-45 | 16729048445 | 10 SYRINGE, GLASS in 1 CARTON (16729-484-45) / 10 mL in 1 SYRINGE, GLASS | | 2021-08-19 | 0000-00-00 | No | No | Current |
| 16729-484-90 | 16729048490 | 10 SYRINGE, GLASS in 1 CARTON (16729-484-90) / 5 mL in 1 SYRINGE, GLASS | | 2021-08-19 | 0000-00-00 | No | No | Current |