FDA.reportPublic FDA data

Propofol

Product NDC
72572-590
11-digit product format
725720590
Labeler code
72572
Product ID
72572-590_53af19df-7a6e-41e1-9fb1-1c5c20b1ec7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Civica, Inc
Application
ANDA205576
Marketing category
ANDA
Marketing start
2021-07-16
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 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
A205576-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205576-001AB

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 22:54:322026-06A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205576-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PropofolPROPOFOLCivica, Inc9ba70032-40c2-41c5-9f99-d1f94032d3dc2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205576
application number: ANDA205576
ndc (product): 72572-590
PropofolPROPOFOLPfizer Laboratories Div Pfizer Inc3acf8e6c-827d-11e2-9e96-0800200c9a662025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205576
application number: ANDA205576

Additional Listing Data#

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

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
9ba70032-40c2-41c5-9f99-d1f94032d3dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dd1a36-1efc-430d-94c2-9f49a850da5fProduct name620250317
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-590-01Propofol20 mL in 1 VIALINJECTION, EMULSION207
72572-590-10Propofol10 in 1 CARTONINJECTION, EMULSION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-590-01ML - Milliliter72572-59061e90f29-5b96-4ac5-a69c-90e4f720267d12021-10-08
72572-590-10ML - Milliliter72572-59014882035-7421-42ef-8ffc-40133c5fe5ea12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-590PROPOFOL INJECTION, EMULSION [CIVICA, INC]5Current NDC, Legacy NDC, 2 package rows20230926_9ba70032-40c2-41c5-9f99-d1f94032d3dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808224propofol 200 MG in 20 ML InjectionPSN9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808222propofol 500 MG in 50 ML InjectionPSN9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808217100 ML propofol 10 MG/ML InjectionSCD9ba70032-40c2-41c5-9f99-d1f94032d3dc7
180822420 ML propofol 10 MG/ML InjectionSCD9ba70032-40c2-41c5-9f99-d1f94032d3dc7
180822250 ML propofol 10 MG/ML InjectionSCD9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808217propofol 1000 MG per 100 ML InjectionSY9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808224propofol 200 MG per 20 ML InjectionSY9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808222propofol 500 MG per 50 ML InjectionSY9ba70032-40c2-41c5-9f99-d1f94032d3dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-590-017257205900120 mL in 1 VIAL20 mlHistorical
72572-590-107257205901010 VIAL in 1 CARTON (72572-590-10) / 20 mL in 1 VIAL (72572-590-01) 10 vial2021-07-160000-00-00NoNoCurrent