Propofol

Product NDC
0069-0209
11-digit product format
000690209
Labeler code
0069
Product ID
0069-0209_c56a182a-6142-428f-9ac0-0f4dce23af7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
ANDA205576
Marketing category
ANDA
Marketing start
2020-10-05
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0069-02090069-0209-05DDiscontinued by firm2026-08-17
excluded packagepackage0069-02090069-0209-25DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0069-0209-25DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0069-0209-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0069-0209-25DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0069-0209-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0069-0209-25DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0069-0209-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0069-0209-25DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0069-0209-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0069-0209-25DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0069-0209-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0069-0209-25DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0069-0209-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0069-0209-25DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0069-0209-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0069-0209-25DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0069-0209-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0069-0209-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0069-0209-05DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0069-0209-25DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0069-0209-05DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0069-0209-25DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0069-0209-05DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0069-0209-25DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0069-0209-05DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0069-0209-25DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…

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
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
2026-08-18 06:07:402026-07A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-164b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205576-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2020-09-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205576-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205576-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205576-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205576-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205576-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205576-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205576-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205576-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205576-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205576-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205576-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205576-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205576-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205576-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205576-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205576-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205576-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205576-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205576-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205576-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205576-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205576-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205576-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205576-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205576-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205576-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205576-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205576-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205576-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205576-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205576-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205576-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205576-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205576-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205576-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205576-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205576-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205576-001AB1a50c72e98297…

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
3acf8e6c-827d-11e2-9e96-0800200c9a66Available 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
0069-0209-01Propofol20 mL in 1 VIALINJECTION, EMULSION207
0069-0209-05Propofol5 in 1 CARTONINJECTION, EMULSION57
0069-0209-10Propofol10 in 1 CARTONINJECTION, EMULSION107
0069-0209-25Propofol25 in 1 CARTONINJECTION, EMULSION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0209PROPOFOL INJECTION, EMULSION [PFIZER LABORATORIES DIV PFIZER INC]6Current NDC, Legacy NDC, 4 package rows20250121_3acf8e6c-827d-11e2-9e96-0800200c9a66.zip

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 · 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
PropofolPROPOFOLPfizer Laboratories Div Pfizer Inc3acf8e6c-827d-11e2-9e96-0800200c9a662025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205576
application number: ANDA205576
ndc (product): 0069-0209

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN3acf8e6c-827d-11e2-9e96-0800200c9a667
1808224propofol 200 MG in 20 ML InjectionPSN3acf8e6c-827d-11e2-9e96-0800200c9a667
1808222propofol 500 MG in 50 ML InjectionPSN3acf8e6c-827d-11e2-9e96-0800200c9a667
1808217100 ML propofol 10 MG/ML InjectionSCD3acf8e6c-827d-11e2-9e96-0800200c9a667
180822420 ML propofol 10 MG/ML InjectionSCD3acf8e6c-827d-11e2-9e96-0800200c9a667
180822250 ML propofol 10 MG/ML InjectionSCD3acf8e6c-827d-11e2-9e96-0800200c9a667
1808217propofol 1000 MG per 100 ML InjectionSY3acf8e6c-827d-11e2-9e96-0800200c9a667
1808224propofol 200 MG per 20 ML InjectionSY3acf8e6c-827d-11e2-9e96-0800200c9a667
1808222propofol 500 MG per 50 ML InjectionSY3acf8e6c-827d-11e2-9e96-0800200c9a667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-0209-010006902090120 mL in 1 VIAL20 mlHistorical
0069-0209-05000690209055 in 1 CARTONHistorical
0069-0209-100006902091010 VIAL in 1 CARTON (0069-0209-10) / 20 mL in 1 VIAL (0069-0209-01) 10 vial2020-10-050000-00-00NoNoCurrent
0069-0209-250006902092525 in 1 CARTONHistorical