PROPOFOL
- Product NDC
- 0404-9943
- 11-digit product format
- 004049943
- Labeler code
- 0404
- Product ID
- 0404-9943_c5524e9d-ded6-4074-9637-9a28dc638933
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propofol
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA205307
- Marketing category
- ANDA
- Marketing start
- 2022-01-13
- 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
- 2023-12-31
- 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 | 0404-9943 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0404-9943 | 0404-9943-50 | 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 |
|---|
| 0404-9943-50 | 00404994350 | 1 VIAL in 1 BAG (0404-9943-50) > 50 mL in 1 VIAL | 1 vial | 2022-01-13 | 0000-00-00 | No | No | Current |