Propofol 1%

Manufacturer: Genixus
Effective date: 2023-12-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:56:58

Label at a glance#

ProductPropofol 1%

Active ingredientPROPOFOL

Label structure2 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Propofol injectable emulsion, USP is a sterile, nonpyrogenic white or almost white, homogeneous
emulsion, containing 10 mg/mL of propofol, USP suitable for intravenous administration. Propofol,
USP is chemically described as 2,6-diisopropylphenol and has a molecular weight of 178.27.
The structural formula is:

propofol structure

Propofol, USP is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion.
The pKa is 11. The octanol/water partition coefficient for propofol, USP is 6761:1 at a pH of 4.5 to
7.4. In addition to the active component, propofol, USP the formulation also contains
soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg phospholipids (12 mg/mL); and benzyl alcohol
(0.15%); with sodium hydroxide to adjust pH. Propofol injectable emulsion, USP is isotonic and has
a pH of 5.5 to 7.4.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Propofol 1% 100mg/10ml

Propofol 1% 200mg/20ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
312674	propofol 10 MG/ML Injectable Suspension	PSN	3
312674	propofol 10 MG/ML Injectable Suspension	SCD	3
312674	propofol 1 % Injectable Suspension	SY	3
312674	propofol 200 MG per 20 ML Injectable Suspension	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PROPOFOL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b5dd1a36-1efc-430d-94c2-9f49a850da5f	Product name	6	20250317
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80700-113-11	2025-01-30	C162847	48780-1	2cef2736-9ae3-d83d-e063-dadaa90ab31f	e067b07a-b467-0f49-e053-2a95a90a79b7
80700-113-12	2025-01-30	C162847	48780-1	2cef2736-9ae3-d83d-e063-dadaa90ab31f	e067b07a-b467-0f49-e053-2a95a90a79b7
80700-113-21	2025-01-30	C162847	48780-1	2cef2736-9ae3-d83d-e063-dadaa90ab31f	e067b07a-b467-0f49-e053-2a95a90a79b7
80700-113-22	2025-01-30	C162847	48780-1	2cef2736-9ae3-d83d-e063-dadaa90ab31f	e067b07a-b467-0f49-e053-2a95a90a79b7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80700-113-10	Propofol 1%	10 mL in 1 SYRINGE, PLASTIC	INJECTION, EMULSION	10	3
80700-113-11	Propofol 1%	10 in 1 BAG	INJECTION, EMULSION	10	3
80700-113-12	Propofol 1%	25 in 1 BAG	INJECTION, EMULSION	25	3
80700-113-20	Propofol 1%	20 mL in 1 SYRINGE, PLASTIC	INJECTION, EMULSION	20	3
80700-113-21	Propofol 1%	10 in 1 BAG	INJECTION, EMULSION	10	3
80700-113-22	Propofol 1%	25 in 1 BAG	INJECTION, EMULSION	25	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80700-113	PROPOFOL 1% INJECTION, EMULSION [GENIXUS]	3	6 package rows	20231228_e067b07a-b467-0f49-e053-2a95a90a79b7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-549-10	ML - Milliliter	43598-549	c2531fb5-f1cb-47b4-a408-fe9221967343	1	2019-02-13
43598-549-52	ML - Milliliter	43598-549	5767e673-f07f-4ca5-b0e4-fd210e6d458f	1	2019-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Propofol 1%
GLYCERIN
SOYBEAN OIL
PROPOFOL
EGG PHOSPHOLIPIDS
BENZYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80700-113	80700-113-10, 80700-113-11, 80700-113-12, 80700-113-20, 80700-113-21, 80700-113-22
43598-549

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
SOYBEAN OIL	241ATL177A	IACT
PROPOFOL	YI7VU623SF	ACTIB
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205067-001	PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB		2018-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205067-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205067-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205067-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205067-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205067-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205067-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205067-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205067-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205067-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205067-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205067-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205067-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205067-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205067-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205067-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205067-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205067-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205067-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205067-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205067-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205067-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205067-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205067-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205067-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205067-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205067-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205067-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205067-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205067-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205067-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205067-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205067-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205067-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205067-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205067-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205067-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205067-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205067-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205067-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205067-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205067-001	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0d8333a4-0451-1a58-e063-6294a90a4add			e067b07a-b467-0f49-e053-2a95a90a79b7	2023-12-27		Exact identifier spl id: 0d8333a4-0451-1a58-e063-6294a90a4add spl set id: e067b07a-b467-0f49-e053-2a95a90a79b7
Propofol Injectable Emulsion	PROPOFOL INJECTABLE EMULSION	Dr. Reddy's Laboratories, Inc.	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	2022-09-30	Warnings, Adverse reactions	Exact identifier ndc (product): 43598-549

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.