Home NDC 0069-0248 Propofol
Product NDC 0069-0248
11-digit product format 000690248
Labeler code 0069
Product ID 0069-0248_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 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0069-0248-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0069-0248-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0069-0248-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0069-0248-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0069-0248-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0069-0248-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0069-0248-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0069-0248-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0069-0248-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0069-0248-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0069-0248-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0069-0248-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0069-0248-01 D Discontinued by firm 557ba5c1ecfa…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-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 2026-12-31 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 0069-0248-01 Propofol 100 mL in 1 VIAL INJECTION, EMULSION 100 7 0069-0248-01 Propofol 1 in 1 CARTON INJECTION, EMULSION 1 7 0069-0248-10 Propofol 100 mL in 1 VIAL INJECTION, EMULSION 100 7 0069-0248-10 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 0069-0248 PROPOFOL INJECTION, EMULSION [PFIZER LABORATORIES DIV PFIZER INC] 6 Current NDC, Legacy NDC, 4 package rows 20250121_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.
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 0069-0248-01 00069024801 100 mL in 1 VIAL 100 ml Historical 0069-0248-10 00069024810 10 VIAL in 1 CARTON (0069-0248-10) / 100 mL in 1 VIAL 10 vial 2020-10-05 0000-00-00 No No Current