Atropine Sulfate
- Product NDC
- 0404-9822
- 11-digit product format
- 004049822
- Labeler code
- 0404
- Product ID
- 0404-9822_460368e5-6e69-43c4-b156-1607e22f549f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atropine Sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2022-01-09
- Marketing end
- 0000-00-00
- Substance
- ATROPINE SULFATE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0404-9822 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 0404-9822 | 0404-9822-05 | D | Discontinued by firm | 2026-09-14 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0404-9822-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0404-9822-05 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0404-9822-05 | 00404982205 | 1 SYRINGE in 1 BAG (0404-9822-05) > 5 mL in 1 SYRINGE | 1 syringe | 2022-01-09 | 0000-00-00 | No | No | Current |