Atropine sulfate
- Product NDC
- 70069-583
- 11-digit product format
- 700690583
- Labeler code
- 70069
- Product ID
- 70069-583_43d3dd59-36b1-493f-86a3-c5eee9750ee8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA215618
- Marketing category
- ANDA
- Marketing start
- 2025-02-12
- Substance
- ATROPINE SULFATE
- Active strength
- 10 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
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 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 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 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 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 |
|---|---|---|---|---|---|---|
| 70069-583-01 | Atropine sulfate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 8 | |
| 70069-583-01 | Atropine sulfate | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70069-583-01 | ML - Milliliter | 70069-583 | 640f6dcd-ec87-4524-81a0-5ea17d75d5e6 | 1 | 2025-06-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190655 | atropine sulfate 1 % Ophthalmic Solution | PSN | e30491ed-938e-4ef4-aa23-a2e94cbab0ed | 8 |
| 1190655 | atropine sulfate 10 MG/ML Ophthalmic Solution | SCD | e30491ed-938e-4ef4-aa23-a2e94cbab0ed | 8 |
| 1190655 | atropine sulfate 1 % Ophthalmic Solution | SY | e30491ed-938e-4ef4-aa23-a2e94cbab0ed | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70069-583-01 | 70069058301 | 1 BOTTLE in 1 CARTON (70069-583-01) / 15 mL in 1 BOTTLE | 1 bottle | 2025-02-12 | No | No | Historical |