ACETAMINOPHEN
- Product NDC
- 0615-8409
- Requested package NDC
- 0615-8409-39
- 11-digit product format
- 006158409
- Labeler code
- 0615
- Product ID
- 0615-8409_fc6ccc87-6e4a-40a5-8af2-479db1c618f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2011-07-18
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- 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 package | package | 0615-8409 | 0615-8409-39 | D | Discontinued by firm | 2026-10-12 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0615-8409-39 | 00615840939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8409-39) | 2021-10-05 | 0000-00-00 | No | No | Current |