PROPOFOL

Product NDC: 0409-0501
11-digit product format: 004090501
Labeler code: 0409
Product ID: 0409-0501_85df7d34-d827-46d8-aba9-c99c116f654a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPOFOL
Dosage form: INJECTION, EMULSION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA077908
Marketing category: ANDA
Marketing start: 2026-08-17
Substance: PROPOFOL
Active strength: 10 mg/mL
Pharmacologic classes: General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A077908-001	PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB		2006-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077908-001	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	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2006-03-17	`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	A077908-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077908-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077908-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077908-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077908-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077908-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077908-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077908-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077908-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077908-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077908-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077908-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077908-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077908-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077908-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077908-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077908-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077908-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077908-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077908-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077908-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077908-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077908-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077908-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077908-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077908-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077908-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077908-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077908-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077908-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077908-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077908-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077908-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077908-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077908-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077908-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077908-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077908-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077908-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077908-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: PROPOFOL
Listing expiration: 2027-12-31

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
28d7ba00-f824-4e55-139a-03f509c099db	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROPOFOL	ACTIVE INGREDIENT	YI7VU623SF	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6
PROPOFOL	ACTIVE MOIETY	YI7VU623SF	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	6

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPOFOL	PROPOFOL	Hospira, Inc.	28d7ba00-f824-4e55-139a-03f509c099db	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077908 application number: ANDA077908 ndc (product): 0409-0501
PROPOFOL	PROPOFOL	HF Acquisition Co LLC, DBA HealthFirst	99af9e0a-c268-84ca-e053-2a95a90a0a3e	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077908 application number: ANDA077908
PROPOFOL	PROPOFOL	HF Acquisition Co LLC, DBA HealthFirst	99c8438a-2b3c-796e-e053-2a95a90a0200	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077908 application number: ANDA077908
PROPOFOL	PROPOFOL	HF Acquisition Co LLC, DBA HealthFirst	7b9599e0-5bad-742d-e053-2991aa0aee97	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077908 application number: ANDA077908

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	28d7ba00-f824-4e55-139a-03f509c099db	25
1808224	propofol 200 MG in 20 ML Injection	PSN	28d7ba00-f824-4e55-139a-03f509c099db	25
1808222	propofol 500 MG in 50 ML Injection	PSN	28d7ba00-f824-4e55-139a-03f509c099db	25
1808217	100 ML propofol 10 MG/ML Injection	SCD	28d7ba00-f824-4e55-139a-03f509c099db	25
1808224	20 ML propofol 10 MG/ML Injection	SCD	28d7ba00-f824-4e55-139a-03f509c099db	25
1808222	50 ML propofol 10 MG/ML Injection	SCD	28d7ba00-f824-4e55-139a-03f509c099db	25
1808217	propofol 1000 MG per 100 ML Injection	SY	28d7ba00-f824-4e55-139a-03f509c099db	25
1808224	propofol 200 MG per 20 ML Injection	SY	28d7ba00-f824-4e55-139a-03f509c099db	25
1808222	propofol 500 MG per 50 ML Injection	SY	28d7ba00-f824-4e55-139a-03f509c099db	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0409-0501-98	00409050198	20 VIAL, SINGLE-DOSE in 1 TRAY (0409-0501-98) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-0501-97)	2026-08-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPOFOL - Hospira, Inc. \| Pfizer Healthcare India Private Limited	Hospira, Inc. \| Pfizer Healthcare India Private Limited	2026-08-13	HUMAN PRESCRIPTION DRUG LABEL	26