Diprivan

Product NDC: 65219-800
11-digit product format: 652190800
Labeler code: 65219
Product ID: 65219-800_8d8838c0-3c0c-4732-ade1-12f76001c50b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPOFOL
Dosage form: INJECTION, EMULSION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA019627
Marketing category: NDA
Marketing start: 2020-01-13
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019627-001	DIPRIVAN	PROPOFOL	10MG/ML	INJECTABLE / INJECTION			1989-10-02
N019627-002	DIPRIVAN	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019627-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`bb7c543d1eb4…`

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	N019627-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019627-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019627-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019627-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019627-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019627-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019627-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019627-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019627-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019627-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019627-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019627-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019627-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019627-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019627-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019627-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019627-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019627-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019627-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019627-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019627-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019627-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019627-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019627-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019627-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019627-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019627-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019627-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019627-002	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`8869cabd3fbd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diprivan
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1808224	Internal RxNorm lookup
1808225	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
5cec3b97-5183-4a9d-accd-21e76c99d3dd	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
65219-800-01	Diprivan	20 mL in 1 VIAL	INJECTION, EMULSION	20		6
65219-800-10	Diprivan	10 in 1 CARTON	INJECTION, EMULSION	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-800	DIPRIVAN (PROPOFOL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20240425_5cec3b97-5183-4a9d-accd-21e76c99d3dd.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	e3105799-a4b6-f3f4-e6e2-b2b29bbdb538	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	fee3bd4a-ade3-41fa-839a-48e9af69bcf4	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	d1ae9e26-ffd6-43df-bbd6-869cdede6afe	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	ee0c3437-614d-4631-a061-257f5f60c70b	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	5cec3b97-5183-4a9d-accd-21e76c99d3dd	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627 ndc (product): 65219-800

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
1808225	DIPRIVAN 200 MG in 20 ML Injection	PSN	5cec3b97-5183-4a9d-accd-21e76c99d3dd	6
1808224	propofol 200 MG in 20 ML Injection	PSN	5cec3b97-5183-4a9d-accd-21e76c99d3dd	6
1808225	20 ML propofol 10 MG/ML Injection [Diprivan]	SBD	5cec3b97-5183-4a9d-accd-21e76c99d3dd	6
1808224	20 ML propofol 10 MG/ML Injection	SCD	5cec3b97-5183-4a9d-accd-21e76c99d3dd	6
1808225	20 ML Diprivan 10 MG/ML Injection	SY	5cec3b97-5183-4a9d-accd-21e76c99d3dd	6
1808225	Diprivan 200 MG per 20 ML Injection	SY	5cec3b97-5183-4a9d-accd-21e76c99d3dd	6
1808224	propofol 200 MG per 20 ML Injection	SY	5cec3b97-5183-4a9d-accd-21e76c99d3dd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-800-01	65219080001	20 mL in 1 VIAL	20 ml					Historical
65219-800-10	65219080010	10 VIAL in 1 CARTON (65219-800-10) / 20 mL in 1 VIAL (65219-800-01)	10 vial	2020-01-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diprivan® (Propofol) Injectable Emulsion, USP	Fresenius Kabi USA, LLC \| Fresenius Kabi AB Uppsala	2024-04-18	HUMAN PRESCRIPTION DRUG LABEL	6