Home NDC 72572-584-20 Propofol
Product NDC 72572-584
Requested package NDC 72572-584-20
11-digit product format 725720584
Labeler code 72572
Product ID 72572-584_9db78e67-e664-4151-a8bf-46d2225bfce5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propofol
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Civica, Inc.
Application ANDA074848
Marketing category ANDA
Marketing start 2020-09-03
Marketing end 0000-00-00
Substance PROPOFOL
Active strength 10 mg/mL
Pharmacologic classes General Anesthesia [PE],General Anesthetic [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074848-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074848-001 AB
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 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION 2005-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION 2005-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION 2005-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION 2005-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROPOFOL PROPOFOL Hikma Pharmaceuticals USA Inc. fdb77e13-f5a7-4c4a-9f8e-338b702239c8 2022-11-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074848 application number: ANDA074848
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72572-584-20 72572058420 20 VIAL, SINGLE-USE in 1 CARTON (72572-584-20) > 50 mL in 1 VIAL, SINGLE-USE (72572-584-01) 2020-09-03 0000-00-00 No No Current