PROPOFOL

Product NDC: 0409-4699
11-digit product format: 004094699
Labeler code: 0409
Product ID: 0409-4699_6b15a686-96ff-4f19-8638-bce64d91e266
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPOFOL
Dosage form: INJECTION, EMULSION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA077908
Marketing category: ANDA
Marketing start: 2006-04-03
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0409-4699	0409-4699-30	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

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
2026-08-01 22:54:32	2026-06	A077908-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB		2006-03-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077908-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077908 application number: ANDA077908 ndc (product): 0409-4699
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

Additional Listing Data#

Finished product: Yes
Brand name base: PROPOFOL
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-4699-24	PROPOFOL	10 in 1 TRAY	INJECTION, EMULSION	10	25
0409-4699-30	PROPOFOL	5 in 1 CARTON	INJECTION, EMULSION	5	25
0409-4699-33	PROPOFOL	20 in 1 TRAY	INJECTION, EMULSION	20	25
0409-4699-50	PROPOFOL	20 mL in 1 VIAL	INJECTION, EMULSION	20	25
0409-4699-53	PROPOFOL	50 mL in 1 VIAL	INJECTION, EMULSION	50	25
0409-4699-54	PROPOFOL	100 mL in 1 VIAL	INJECTION, EMULSION	100	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-4699-24	ML - Milliliter	0409-4699	777f4e9b-549e-4664-ab8b-0a13e6a8e34b	1	2012-07-24
0409-4699-30	ML - Milliliter	0409-4699	67568f0b-c056-489a-a153-70baaf973c6b	1	2012-07-24
0409-4699-33	ML - Milliliter	0409-4699	149823c2-a865-4c71-9c43-3a3d542be933	1	2012-07-24
0409-4699-50	ML - Milliliter	0409-4699	bf2046c8-c887-4dba-8781-5d058824cdbd	1	2017-07-07
0409-4699-53	ML - Milliliter	0409-4699	07606c22-bb98-4184-85e5-eb34e1ee6a36	1	2016-11-08
0409-4699-54	ML - Milliliter	0409-4699	5adb6d59-bb5b-459c-9ecc-ab15fcf9e29c	1	2017-07-07
0409-4699-61	ML - Milliliter	0409-4699	3a5cafc7-288d-4fe0-8432-ed3c2c7180a0	1	2012-07-24
0409-4699-62	ML - Milliliter	0409-4699	0e24fad7-b169-4f9a-8bd1-e16c43d0972d	1	2012-07-24
0409-4699-63	ML - Milliliter	0409-4699	b2dbe776-2557-4d67-ac8d-085945e423f2	1	2012-07-24

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
PROPOFOL	ACTIVE INGREDIENT	YI7VU623SF	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1
PROPOFOL	ACTIVE MOIETY	YI7VU623SF	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-4699	PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]	22	Current NDC, Legacy NDC, 6 package rows	20241206_28d7ba00-f824-4e55-139a-03f509c099db.zip

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
1808224	propofol 200 MG in 20 ML Injection	PSN	7b9599e0-5bad-742d-e053-2991aa0aee97	4
1808224	20 ML propofol 10 MG/ML Injection	SCD	7b9599e0-5bad-742d-e053-2991aa0aee97	4
1808224	propofol 200 MG per 20 ML Injection	SY	7b9599e0-5bad-742d-e053-2991aa0aee97	4
1808217	propofol 1000 MG in 100 ML Injection	PSN	99af9e0a-c268-84ca-e053-2a95a90a0a3e	3
1808222	propofol 500 MG in 50 ML Injection	PSN	99c8438a-2b3c-796e-e053-2a95a90a0200	3
1808217	100 ML propofol 10 MG/ML Injection	SCD	99af9e0a-c268-84ca-e053-2a95a90a0a3e	3
1808222	50 ML propofol 10 MG/ML Injection	SCD	99c8438a-2b3c-796e-e053-2a95a90a0200	3
1808217	propofol 1000 MG per 100 ML Injection	SY	99af9e0a-c268-84ca-e053-2a95a90a0a3e	3
1808222	propofol 500 MG per 50 ML Injection	SY	99c8438a-2b3c-796e-e053-2a95a90a0200	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-4699-24	00409469924	10 VIAL in 1 TRAY (0409-4699-24) / 100 mL in 1 VIAL (0409-4699-54)	10 vial	2006-04-03	0000-00-00	No	No	Current
0409-4699-30	00409469930	5 VIAL in 1 CARTON (0409-4699-30) > 20 mL in 1 VIAL (0409-4699-50)	5 vial	2006-04-04	0000-00-00	No	No	Current
0409-4699-33	00409469933	20 VIAL in 1 TRAY (0409-4699-33) / 50 mL in 1 VIAL (0409-4699-53)	20 vial	2006-04-03	0000-00-00	No	No	Current
0409-4699-50	00409469950	20 mL in 1 VIAL	20 ml					Historical
0409-4699-53	00409469953	50 mL in 1 VIAL	50 ml					Historical
0409-4699-54	00409469954	100 mL in 1 VIAL	100 ml					Historical

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	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	25
PROPOFOL INJECTABLE EMULSION 1g/100mL (10mg/mL) 100mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3
PROPOFOL INJECTABLE EMULSION 500mg/50mL (10mg/mL) 50mLVIAL	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3
PROPOFOL INJECTION EMULSION 200mg/20mL (10mg/mL) VIAL	HF Acquisition Co LLC, DBA HealthFirst	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	4
PROPOFOL Injectable Emulsion PAA 109887	General Injectables and Vaccines, Inc	2020-05-06	HUMAN PRESCRIPTION DRUG LABEL	7