FDA.reportPublic FDA data

PROPOFOL

Product NDC
0409-4699
Requested package NDC
0409-4699-30
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0409-46990409-4699-30DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077908-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077908-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077908-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2006-03-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077908-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPOFOLPROPOFOLHospira, Inc.28d7ba00-f824-4e55-139a-03f509c099db2025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077908
application number: ANDA077908
ndc (package): 0409-4699-30
ndc (product): 0409-4699
ndc11 (package): 00409469930
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst99af9e0a-c268-84ca-e053-2a95a90a0a3e2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077908
application number: ANDA077908
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst99c8438a-2b3c-796e-e053-2a95a90a02002025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077908
application number: ANDA077908
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst7b9599e0-5bad-742d-e053-2991aa0aee972022-12-09Warnings, Adverse reactionsExact 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
IngredientStrength
PROPOFOL10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YI7VU623SFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
28d7ba00-f824-4e55-139a-03f509c099dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dd1a36-1efc-430d-94c2-9f49a850da5fProduct name620250317
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4699-24PROPOFOL10 in 1 TRAYINJECTION, EMULSION1025
0409-4699-30PROPOFOL5 in 1 CARTONINJECTION, EMULSION525
0409-4699-33PROPOFOL20 in 1 TRAYINJECTION, EMULSION2025
0409-4699-50PROPOFOL20 mL in 1 VIALINJECTION, EMULSION2025
0409-4699-53PROPOFOL50 mL in 1 VIALINJECTION, EMULSION5025
0409-4699-54PROPOFOL100 mL in 1 VIALINJECTION, EMULSION10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4699-24ML - Milliliter0409-4699777f4e9b-549e-4664-ab8b-0a13e6a8e34b12012-07-24
0409-4699-30ML - Milliliter0409-469967568f0b-c056-489a-a153-70baaf973c6b12012-07-24
0409-4699-33ML - Milliliter0409-4699149823c2-a865-4c71-9c43-3a3d542be93312012-07-24
0409-4699-50ML - Milliliter0409-4699bf2046c8-c887-4dba-8781-5d058824cdbd12017-07-07
0409-4699-53ML - Milliliter0409-469907606c22-bb98-4184-85e5-eb34e1ee6a3612016-11-08
0409-4699-54ML - Milliliter0409-46995adb6d59-bb5b-459c-9ecc-ab15fcf9e29c12017-07-07
0409-4699-61ML - Milliliter0409-46993a5cafc7-288d-4fe0-8432-ed3c2c7180a012012-07-24
0409-4699-62ML - Milliliter0409-46990e24fad7-b169-4f9a-8bd1-e16c43d0972d12012-07-24
0409-4699-63ML - Milliliter0409-4699b2dbe776-2557-4d67-ac8d-085945e423f212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPOFOLACTIVE INGREDIENTYI7VU623SFPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
PROPOFOLACTIVE MOIETYYI7VU623SFPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
SOYBEAN OILINACTIVE INGREDIENT241ATL177APROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
PROPOFOLACTIVE INGREDIENTYI7VU623SFPROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1
PROPOFOLACTIVE MOIETYYI7VU623SFPROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVPROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177APROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4699PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]22Current NDC, Legacy NDC, 6 package rows20241206_28d7ba00-f824-4e55-139a-03f509c099db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN28d7ba00-f824-4e55-139a-03f509c099db25
1808224propofol 200 MG in 20 ML InjectionPSN28d7ba00-f824-4e55-139a-03f509c099db25
1808222propofol 500 MG in 50 ML InjectionPSN28d7ba00-f824-4e55-139a-03f509c099db25
1808217100 ML propofol 10 MG/ML InjectionSCD28d7ba00-f824-4e55-139a-03f509c099db25
180822420 ML propofol 10 MG/ML InjectionSCD28d7ba00-f824-4e55-139a-03f509c099db25
180822250 ML propofol 10 MG/ML InjectionSCD28d7ba00-f824-4e55-139a-03f509c099db25
1808217propofol 1000 MG per 100 ML InjectionSY28d7ba00-f824-4e55-139a-03f509c099db25
1808224propofol 200 MG per 20 ML InjectionSY28d7ba00-f824-4e55-139a-03f509c099db25
1808222propofol 500 MG per 50 ML InjectionSY28d7ba00-f824-4e55-139a-03f509c099db25
1808224propofol 200 MG in 20 ML InjectionPSN7b9599e0-5bad-742d-e053-2991aa0aee974
180822420 ML propofol 10 MG/ML InjectionSCD7b9599e0-5bad-742d-e053-2991aa0aee974
1808224propofol 200 MG per 20 ML InjectionSY7b9599e0-5bad-742d-e053-2991aa0aee974
1808217propofol 1000 MG in 100 ML InjectionPSN99af9e0a-c268-84ca-e053-2a95a90a0a3e3
1808222propofol 500 MG in 50 ML InjectionPSN99c8438a-2b3c-796e-e053-2a95a90a02003
1808217100 ML propofol 10 MG/ML InjectionSCD99af9e0a-c268-84ca-e053-2a95a90a0a3e3
180822250 ML propofol 10 MG/ML InjectionSCD99c8438a-2b3c-796e-e053-2a95a90a02003
1808217propofol 1000 MG per 100 ML InjectionSY99af9e0a-c268-84ca-e053-2a95a90a0a3e3
1808222propofol 500 MG per 50 ML InjectionSY99c8438a-2b3c-796e-e053-2a95a90a02003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4699-30004094699305 VIAL in 1 CARTON (0409-4699-30) > 20 mL in 1 VIAL (0409-4699-50) 5 vial2006-04-040000-00-00NoNoCurrent