Atropine Sulfate
- Product NDC
- 0641-6274
- 11-digit product format
- 006416274
- Labeler code
- 0641
- Product ID
- 0641-6274_4298dd9c-15f7-4bab-be40-c0250eb01886
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVASCULAR
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA217345
- Marketing category
- ANDA
- Marketing start
- 2025-11-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c78bd43-efb4-4aeb-b7d8-eff1532f7822 | Product name | 4 | 20250801 |
| 41231c1e-8789-4da7-ac52-77fa90a85bf5 | Product name | 2 | 20250304 |
| e77ab9a2-80cf-4832-bff0-469bbc7cbcd0 | Product name | 2 | 20250214 |
| 5f84b7a7-523a-f042-dffb-1dadcd9b2407 | Product name | 4 | 20240110 |
| 0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca | Product name | 1 | 20230719 |
| 04cd5dc0-102f-46cb-8dbc-ca38dd2628d0 | Product name | 3 | 20230317 |
| dfd25202-b8d2-4628-9213-f3e0f9eafce5 | Product name | 4 | 20210513 |
| 4199bf9b-4718-828a-6dd6-ac2fbbd61687 | Product name | 1 | 20140508 |
| 4edd8af5-cea7-ae42-8023-e91c5335db1d | Product name | 1 | 20140508 |
| d3908afb-7784-440f-c406-88294732d36a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6274-01 | Atropine Sulfate | 1 mL in 1 VIAL | INJECTION | 1 | 4 | |
| 0641-6274-25 | Atropine Sulfate | 25 in 1 CARTON | INJECTION | 25 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6274-01 | ML - Milliliter | 0641-6274 | dd49e06b-691a-46af-a5fb-7e9bc47b8a83 | 1 | 2025-12-16 |
| 0641-6274-25 | ML - Milliliter | 0641-6274 | 7cdcf051-6d54-4d59-a01a-09aa64c17096 | 1 | 2025-12-16 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1666781 | atropine sulfate 0.4 MG in 1 ML Injection | PSN | a66eecf9-2d8b-4e2d-8a05-d718dcbc3542 | 4 |
| 1190795 | atropine sulfate 1 MG in 1 ML Injection | PSN | a66eecf9-2d8b-4e2d-8a05-d718dcbc3542 | 4 |
| 1666781 | 1 ML atropine sulfate 0.4 MG/ML Injection | SCD | a66eecf9-2d8b-4e2d-8a05-d718dcbc3542 | 4 |
| 1190795 | 1 ML atropine sulfate 1 MG/ML Injection | SCD | a66eecf9-2d8b-4e2d-8a05-d718dcbc3542 | 4 |
| 1666781 | atropine sulfate 0.4 MG per 1 ML Injection | SY | a66eecf9-2d8b-4e2d-8a05-d718dcbc3542 | 4 |
| 1190795 | atropine sulfate 1 MG per 1 ML Injection | SY | a66eecf9-2d8b-4e2d-8a05-d718dcbc3542 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0641-6274-01 | 00641627401 | 1 mL in 1 VIAL | 1 ml | Historical | |||
| 0641-6274-25 | 00641627425 | 25 VIAL in 1 CARTON (0641-6274-25) / 1 mL in 1 VIAL (0641-6274-01) | 25 vial | 2025-11-07 | No | No | Historical |