Home NDC 72572-590 Propofol
Product NDC 72572-590
11-digit product format 725720590
Labeler code 72572
Product ID 72572-590_53af19df-7a6e-41e1-9fb1-1c5c20b1ec7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propofol
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Civica, Inc
Application ANDA205576
Marketing category ANDA
Marketing start 2021-07-16
Substance PROPOFOL
Active strength 10 mg/mL
Pharmacologic classes General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205576-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205576-001 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.
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 2026-08-18 06:07:40 2026-07 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205576-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2020-09-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Propofol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPOFOL 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YI7VU623SF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1808217 Internal RxNorm lookup 1808222 Internal RxNorm lookup 1808224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72572-590-01 Propofol 20 mL in 1 VIAL INJECTION, EMULSION 20 7 72572-590-10 Propofol 10 in 1 CARTON INJECTION, EMULSION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72572-590 PROPOFOL INJECTION, EMULSION [CIVICA, INC] 5 Current NDC, Legacy NDC, 2 package rows 20230926_9ba70032-40c2-41c5-9f99-d1f94032d3dc.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72572-590-01 72572059001 20 mL in 1 VIAL 20 ml Historical 72572-590-10 72572059010 10 VIAL in 1 CARTON (72572-590-10) / 20 mL in 1 VIAL (72572-590-01) 10 vial 2021-07-16 0000-00-00 No No Current