Propofol
- Product NDC
- 52584-054
- 11-digit product format
- 525840054
- Labeler code
- 52584
- Product ID
- 52584-054_417d6f96-96eb-4d5c-9cb0-86eed3086f9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propofol
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA205307
- Marketing category
- ANDA
- Marketing start
- 2018-04-11
- Marketing end
- 0000-00-00
- Substance
- PROPOFOL
- Active strength
- 10 mg/mL
- Pharmacologic classes
- General Anesthesia [PE],General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 52584-054 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 52584-054 | 52584-054-57 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A205307-001 | PROPOFOL | PROPOFOL | 10MG/ML | INJECTABLE / INJECTION | | | 2015-12-22 |