85534-0100
- Product NDC
- 85534-0100
- 11-digit product format
- 855340100
- Labeler code
- 85534
- Product ID
- 85534-0100_572c7022-2ba7-4dd7-e063-6394a90a09f3
- Type
- BULK INGREDIENT
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- KIT
- Marketing category
- BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
- Marketing start
- 2012-08-29
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 85534-0100 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | ||
| unfinished package | package | 85534-0100 | 85534-0100-0 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2027-12-31
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 85534-0100-0 | 85534010000 | 1 KIT in 1 KIT (85534-0100-0) * 58.8 g in 1 BOTTLE, PLASTIC * 1.2 g in 1 BOTTLE, PLASTIC | 1 kit | 22-JUL-26 | Current |