Diprivan

Product NDC
52584-269
11-digit product format
525840269
Labeler code
52584
Product ID
52584-269_bc7ce430-9a37-4654-b256-3a7ef0643e9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diprivan
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
NDA019627
Marketing category
NDA
Marketing start
2010-03-01
Marketing end
0000-00-00
Substance
PROPOFOL
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE],General Anesthetic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 productproduct52584-269IInactivated by FDA2026-08-17
excluded packagepackage52584-26952584-269-50DDiscontinued 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 · 34 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52584-269-50DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52584-269-50DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52584-269-50DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52584-269-50DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52584-269-50DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52584-269-50DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52584-269-50DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52584-269-50DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52584-269-50DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52584-269-50DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52584-269-50DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52584-269-50DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019627-001DIPRIVANPROPOFOL10MG/MLINJECTABLE / INJECTION1989-10-02
N019627-002DIPRIVANPROPOFOL10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019627-002AB

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019627-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019627-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019627-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019627-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019627-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019627-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019627-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019627-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019627-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019627-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019627-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019627-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019627-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019627-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019627-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019627-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019627-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019627-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019627-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019627-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019627-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019627-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019627-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019627-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019627-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019627-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N019627-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019627-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019627-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019627-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019627-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019627-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019627-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019627-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019627-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019627-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019627-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019627-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019627-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019627-002AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019627-00284760102024-12-01Drug substance, Drug product2013-07-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019627-0028476010*PED2025-06-01Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N019627-0028476010*PED2025-06-01Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019627-0028476010*PED2025-06-01Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019627-0028476010*PED2025-06-01Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019627-00284760102024-12-01Drug substance, Drug product2013-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019627-0028476010*PED2025-06-01Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019627-00284760102024-12-01Drug substance, Drug product2013-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019627-0028476010*PED2025-06-01Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019627-00284760102024-12-01Drug substance, Drug product2013-07-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019627-0028476010*PED2025-06-01Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019627-00284760102024-12-01Drug substance, Drug product2013-07-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019627-0028476010*PED2025-06-01Pediatric extensiond8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019627-00284760102024-12-01Drug substance, Drug product2013-07-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019627-0028476010*PED2025-06-01Pediatric extensiond06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019627-00284760102024-12-01Drug substance, Drug product2013-07-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019627-0028476010*PED2025-06-01Pediatric extension79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019627-00284760102024-12-01Drug substance, Drug product2013-07-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019627-0028476010*PED2025-06-01Pediatric extension301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019627-00284760102024-12-01Drug substance, Drug product2013-07-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019627-0028476010*PED2025-06-01Pediatric extension1e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019627-00284760102024-12-01Drug substance, Drug product2013-07-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019627-0028476010*PED2025-06-01Pediatric extension8072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019627-00284760102024-12-01Drug substance, Drug product2013-07-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019627-0028476010*PED2025-06-01Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019627-00284760102024-12-01Drug substance, Drug product2013-07-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019627-0028476010*PED2025-06-01Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019627-00284760102024-12-01Drug substance, Drug product2013-07-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019627-0028476010*PED2025-06-01Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019627-00284760102024-12-01Drug substance, Drug product2013-07-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019627-0028476010*PED2025-06-01Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019627-00284760102024-12-01Drug substance, Drug product2013-07-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019627-0028476010*PED2025-06-01Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019627-00284760102024-12-01Drug substance, Drug product2013-07-02782e0a99824c…
2021-12-28 21:50 UTC2021-12N019627-0028476010*PED2025-06-01Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019627-00284760102024-12-01Drug substance, Drug product2013-07-0287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019627-0028476010*PED2025-06-01Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N019627-00284760102024-12-01Drug substance, Drug product2013-07-025aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019627-0028476010*PED2025-06-01Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019627-00284760102024-12-01Drug substance, Drug product2013-07-028869cabd3fbd…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dd1a36-1efc-430d-94c2-9f49a850da5fProduct name620250317

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-269-502020-01-31C16284748780-19d75b9d0-43ff-f424-e053-dadaa90a57ceDiprivan 1% Injection Emulsion (propofol) 10 mg/mL Injectable Emulsion 50 mL Vial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-269-50Diprivan50 mL in 1 VIALINJECTION, EMULSION503
52584-269-50Diprivan1 in 1 BAGINJECTION, EMULSION13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PropofolACTIVE INGREDIENTYI7VU623SFDIPRIVAN INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]2
PropofolACTIVE MOIETYYI7VU623SFDIPRIVAN INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-269DIPRIVAN INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]3Legacy NDC, 2 package rows20170119_7603f1ba-cfbd-4ec5-881a-13f4832c9893.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiprivanPROPOFOLFresenius Kabi USA, LLCe3105799-a4b6-f3f4-e6e2-b2b29bbdb5382025-09-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLCfee3bd4a-ade3-41fa-839a-48e9af69bcf42025-09-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLCd1ae9e26-ffd6-43df-bbd6-869cdede6afe2025-04-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLCee0c3437-614d-4631-a061-257f5f60c70b2025-02-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLC5cec3b97-5183-4a9d-accd-21e76c99d3dd2024-04-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808222propofol 500 MG in 50 ML InjectionPSN7603f1ba-cfbd-4ec5-881a-13f4832c98933
180822250 ML propofol 10 MG/ML InjectionSCD7603f1ba-cfbd-4ec5-881a-13f4832c98933
1808222propofol 500 MG per 50 ML InjectionSY7603f1ba-cfbd-4ec5-881a-13f4832c98933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52584-269-505258402695050 mL in 1 VIAL50 mlHistorical