FDA.reportPublic FDA data

propofol

Product NDC
71288-730
11-digit product format
712880730
Labeler code
71288
Product ID
71288-730_98e25b4f-43c4-4269-8213-aacb02a75099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA217945
Marketing category
ANDA
Marketing start
2025-12-02
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217945-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2025-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217945-001AB

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
2026-08-18 06:07:402026-07A217945-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2025-12-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217945-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2025-12-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217945-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2025-12-0231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217945-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2025-12-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217945-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217945-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217945-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217945-001AB1a50c72e98297…

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
548d5192-2e5e-4c1b-8f17-940b6e791ae5Available 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
71288-730-50propofol50 mL in 1 VIALINJECTION, EMULSION503
71288-730-51propofol10 in 1 CARTONINJECTION, EMULSION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-730-50ML - Milliliter71288-730b9b7491d-7b87-47da-a6ae-161a8625459412026-04-20
71288-730-51ML - Milliliter71288-730e50b63cb-5d95-45dc-94ee-135ac36ea06212026-04-20

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
propofolPROPOFOLMeitheal Pharmaceuticals Inc.548d5192-2e5e-4c1b-8f17-940b6e791ae52025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217945
application number: ANDA217945
ndc (product): 71288-730

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808224propofol 200 MG in 20 ML InjectionPSN548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808222propofol 500 MG in 50 ML InjectionPSN548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808217100 ML propofol 10 MG/ML InjectionSCD548d5192-2e5e-4c1b-8f17-940b6e791ae53
180822420 ML propofol 10 MG/ML InjectionSCD548d5192-2e5e-4c1b-8f17-940b6e791ae53
180822250 ML propofol 10 MG/ML InjectionSCD548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808217propofol 1000 MG per 100 ML InjectionSY548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808224propofol 200 MG per 20 ML InjectionSY548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808222propofol 500 MG per 50 ML InjectionSY548d5192-2e5e-4c1b-8f17-940b6e791ae53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-730-507128807305050 mL in 1 VIAL50 mlHistorical
71288-730-517128807305110 VIAL in 1 CARTON (71288-730-51) / 50 mL in 1 VIAL (71288-730-50) 10 vial2025-12-02NoNoCurrent