FDA.reportPublic FDA data

Propofol Injectable Emulsion

Product NDC
43598-548
11-digit product format
435980548
Labeler code
43598
Product ID
43598-548_b4a9147e-dfe3-229a-d8d7-6a84e6449f15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol Injectable Emulsion
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA205067
Marketing category
ANDA
Marketing start
2018-11-15
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 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
A205067-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2018-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205067-001AB

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 22:54:322026-06A205067-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2018-11-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205067-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propofol Injectable EmulsionPROPOFOL INJECTABLE EMULSIONDr. Reddy's Laboratories, Inc.800646b8-83a8-01d9-3dc8-bb2ddcb8570c2022-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205067
application number: ANDA205067
ndc (product): 43598-548

Additional Listing Data#

Finished product
Yes
Brand name base
Propofol Injectable Emulsion
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
800646b8-83a8-01d9-3dc8-bb2ddcb8570cAvailable 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
43598-548-21Propofol Injectable Emulsion20 in 1 CARTONINJECTION, EMULSION205
43598-548-50Propofol Injectable Emulsion50 mL in 1 VIALINJECTION, EMULSION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-548-21ML - Milliliter43598-54848d53e5f-ca01-4d83-b9ec-d9d002bda2e512019-02-13
43598-548-50ML - Milliliter43598-548a9035187-4f69-4a5d-95d2-42a4dac6bc2012019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-548PROPOFOL INJECTABLE EMULSION INJECTION, EMULSION [DR. REDDY'S LABORATORIES, INC.]5Current NDC, Legacy NDC, 2 package rows20230401_800646b8-83a8-01d9-3dc8-bb2ddcb8570c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
1808224propofol 200 MG in 20 ML InjectionPSN800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
1808222propofol 500 MG in 50 ML InjectionPSN800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
1808217100 ML propofol 10 MG/ML InjectionSCD800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
180822420 ML propofol 10 MG/ML InjectionSCD800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
180822250 ML propofol 10 MG/ML InjectionSCD800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
1808217propofol 1000 MG per 100 ML InjectionSY800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
1808224propofol 200 MG per 20 ML InjectionSY800646b8-83a8-01d9-3dc8-bb2ddcb8570c5
1808222propofol 500 MG per 50 ML InjectionSY800646b8-83a8-01d9-3dc8-bb2ddcb8570c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-548-214359805482120 VIAL in 1 CARTON (43598-548-21) / 50 mL in 1 VIAL (43598-548-50) 20 vial2018-11-150000-00-00NoNoCurrent
43598-548-504359805485050 mL in 1 VIAL50 mlHistorical