Propofol Injectable Emulsion

Product NDC: 43598-549
11-digit product format: 435980549
Labeler code: 43598
Product ID: 43598-549_b4a9147e-dfe3-229a-d8d7-6a84e6449f15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propofol Injectable Emulsion
Dosage form: INJECTION, EMULSION
Route: INTRAVENOUS
Labeler: Dr. Reddy's Laboratories, Inc.
Application: ANDA205067
Marketing category: ANDA
Marketing start: 2018-11-15
Substance: PROPOFOL
Active strength: 10 mg/mL
Pharmacologic classes: General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A205067-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2018-11-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A205067-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Propofol Injectable Emulsion
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPOFOL	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YI7VU623SF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1808217	Internal RxNorm lookup
1808222	Internal RxNorm lookup
1808224	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
800646b8-83a8-01d9-3dc8-bb2ddcb8570c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-549-10	Propofol Injectable Emulsion	10 in 1 CARTON	INJECTION, EMULSION	10		5
43598-549-52	Propofol Injectable Emulsion	100 mL in 1 VIAL	INJECTION, EMULSION	100		5

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-549	PROPOFOL INJECTABLE EMULSION INJECTION, EMULSION [DR. REDDY'S LABORATORIES, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20230401_800646b8-83a8-01d9-3dc8-bb2ddcb8570c.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propofol Injectable Emulsion	PROPOFOL INJECTABLE EMULSION	Dr. Reddy's Laboratories, Inc.	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	2022-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205067 application number: ANDA205067 ndc (product): 43598-549

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YI7VU623SF	PROPOFOL	2078-54-8	PROPOFOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1808217	propofol 1000 MG in 100 ML Injection	PSN	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808224	propofol 200 MG in 20 ML Injection	PSN	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808222	propofol 500 MG in 50 ML Injection	PSN	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808217	100 ML propofol 10 MG/ML Injection	SCD	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808224	20 ML propofol 10 MG/ML Injection	SCD	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808222	50 ML propofol 10 MG/ML Injection	SCD	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808217	propofol 1000 MG per 100 ML Injection	SY	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808224	propofol 200 MG per 20 ML Injection	SY	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
1808222	propofol 500 MG per 50 ML Injection	SY	800646b8-83a8-01d9-3dc8-bb2ddcb8570c	5
312674	propofol 10 MG/ML Injectable Suspension	PSN	e067b07a-b467-0f49-e053-2a95a90a79b7	3
312674	propofol 10 MG/ML Injectable Suspension	SCD	e067b07a-b467-0f49-e053-2a95a90a79b7	3
312674	propofol 1 % Injectable Suspension	SY	e067b07a-b467-0f49-e053-2a95a90a79b7	3
312674	propofol 200 MG per 20 ML Injectable Suspension	SY	e067b07a-b467-0f49-e053-2a95a90a79b7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-549-10	43598054910	10 VIAL in 1 CARTON (43598-549-10) / 100 mL in 1 VIAL (43598-549-52)	10 vial	2018-11-15	0000-00-00	No	No	Current
43598-549-52	43598054952	100 mL in 1 VIAL	100 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propofol 1% - Genixus	Genixus	2023-12-27	HUMAN PRESCRIPTION DRUG LABEL	3
propofol - Dr. Reddy's Laboratories, Inc. \| Corden Pharma SPA	Dr. Reddy's Laboratories, Inc. \| Corden Pharma SPA	2022-09-30	HUMAN PRESCRIPTION DRUG LABEL	5