Propofol
- Product NDC
- 0591-2136
- 11-digit product format
- 005912136
- Labeler code
- 0591
- Product ID
- 0591-2136_56a483ca-e68c-4847-863d-eb186645673f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propofol
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA205307
- Marketing category
- ANDA
- Marketing start
- 2016-01-07
- Marketing end
- 2023-09-30
- Substance
- PROPOFOL
- Active strength
- 10 mg/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 0591-2136 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0591-2136 | 0591-2136-51 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0591-2136 | 0591-2136-68 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0591-2136 | 0591-2136-95 | 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2136-51 | 00591213651 | 20 VIAL in 1 CARTON (0591-2136-51) > 50 mL in 1 VIAL (0591-2136-55) | 20 vial | 2016-01-07 | 0000-00-00 | No | No | Current |
| 0591-2136-68 | 00591213668 | 10 VIAL in 1 CARTON (0591-2136-68) > 100 mL in 1 VIAL (0591-2136-57) | 10 vial | 2016-01-07 | 0000-00-00 | No | No | Current |
| 0591-2136-95 | 00591213695 | 25 VIAL in 1 CARTON (0591-2136-95) > 20 mL in 1 VIAL (0591-2136-80) | 25 vial | 2016-01-07 | 0000-00-00 | No | No | Current |