Atropine Sulfate
- Product NDC
- 76329-3340
- 11-digit product format
- 763293340
- Labeler code
- 76329
- Product ID
- 76329-3340_697aa53c-f31f-463a-a752-d2faaad354db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- International Medication Systems, Limited
- Application
- ANDA212461
- Marketing category
- ANDA
- Marketing start
- 2021-02-17
- 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 |
|---|---|
| ATROPINE SULFATE | .1 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 03J5ZE7KA5 |
| Rxcui | 1190546 |
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 |
|---|---|---|---|---|---|---|
| 76329-3340-1 | Atropine Sulfate | 1 in 1 CARTON | INJECTION | 1 | 6 | |
| 76329-3340-1 | Atropine Sulfate | 10 in 1 PACKAGE | INJECTION | 10 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76329-3340-1 | ML - Milliliter | 76329-3340 | 8f766000-ede3-4e9c-892b-01f7fdf4b35a | 1 | 2021-04-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76329-3340 | ATROPINE SULFATE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250207_b72d0a82-6163-460f-965a-12f6da47370a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | 46ba6000-b842-449a-8dd4-7bb9dc7a74c5 | 6 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | 739f384f-1a69-4953-93a0-aa6a76de0ecc | 6 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | b72d0a82-6163-460f-965a-12f6da47370a | 6 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | 46ba6000-b842-449a-8dd4-7bb9dc7a74c5 | 6 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | 739f384f-1a69-4953-93a0-aa6a76de0ecc | 6 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | b72d0a82-6163-460f-965a-12f6da47370a | 6 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | 46ba6000-b842-449a-8dd4-7bb9dc7a74c5 | 6 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | 739f384f-1a69-4953-93a0-aa6a76de0ecc | 6 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | b72d0a82-6163-460f-965a-12f6da47370a | 6 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | c0d0ca2a-4267-41b7-e053-2a95a90a4726 | 3 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | c0d0ca2a-4267-41b7-e053-2a95a90a4726 | 3 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | c0d0ca2a-4267-41b7-e053-2a95a90a4726 | 3 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | 3d5c747f-3bf7-2597-e063-6394a90a828c | 2 |
| 1190546 | atropine sulfate 1 MG in 10 ML Prefilled Syringe | PSN | c434062a-cd44-e684-e053-2995a90a91c3 | 2 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | c434062a-cd44-e684-e053-2995a90a91c3 | 2 |
| 1190546 | 10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe | SCD | 3d5c747f-3bf7-2597-e063-6394a90a828c | 2 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | 3d5c747f-3bf7-2597-e063-6394a90a828c | 2 |
| 1190546 | atropine sulfate 1 MG per 10 ML Prefilled Syringe | SY | c434062a-cd44-e684-e053-2995a90a91c3 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76329-3340-1 | 76329334001 | 10 CARTON in 1 PACKAGE (76329-3340-1) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE | 10 carton | 2021-02-17 | 0000-00-00 | No | No | Current |