Home NDC 0409-4699 PROPOFOL
Product NDC 0409-4699
11-digit product format 004094699
Labeler code 0409
Product ID 0409-4699_6b15a686-96ff-4f19-8638-bce64d91e266
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROPOFOL
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA077908
Marketing category ANDA
Marketing start 2006-04-03
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 · 9 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…
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 A077908-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077908-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077908-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2006-03-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 0409-4699-24 PROPOFOL 10 in 1 TRAY INJECTION, EMULSION 10 25 0409-4699-30 PROPOFOL 5 in 1 CARTON INJECTION, EMULSION 5 25 0409-4699-33 PROPOFOL 20 in 1 TRAY INJECTION, EMULSION 20 25 0409-4699-50 PROPOFOL 20 mL in 1 VIAL INJECTION, EMULSION 20 25 0409-4699-53 PROPOFOL 50 mL in 1 VIAL INJECTION, EMULSION 50 25 0409-4699-54 PROPOFOL 100 mL in 1 VIAL INJECTION, EMULSION 100 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROPOFOL ACTIVE INGREDIENT YI7VU623SF PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 PROPOFOL ACTIVE MOIETY YI7VU623SF PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 EGG PHOSPHOLIPIDS INACTIVE INGREDIENT 1Z74184RGV PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 6 PROPOFOL ACTIVE INGREDIENT YI7VU623SF PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1 PROPOFOL ACTIVE MOIETY YI7VU623SF PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1 EGG PHOSPHOLIPIDS INACTIVE INGREDIENT 1Z74184RGV PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A PROPOFOL INJECTION, EMULSION [GENERAL INJECTABLES AND VACCINES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-4699 PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.] 22 Current NDC, Legacy NDC, 6 package rows 20241206_28d7ba00-f824-4e55-139a-03f509c099db.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROPOFOL PROPOFOL Hospira, Inc. 28d7ba00-f824-4e55-139a-03f509c099db 2026-08-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077908 application number: ANDA077908 ndc (product): 0409-4699 PROPOFOL PROPOFOL HF Acquisition Co LLC, DBA HealthFirst 99af9e0a-c268-84ca-e053-2a95a90a0a3e 2025-01-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077908 application number: ANDA077908 PROPOFOL PROPOFOL HF Acquisition Co LLC, DBA HealthFirst 99c8438a-2b3c-796e-e053-2a95a90a0200 2025-01-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077908 application number: ANDA077908 PROPOFOL PROPOFOL HF Acquisition Co LLC, DBA HealthFirst 7b9599e0-5bad-742d-e053-2991aa0aee97 2022-12-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077908 application number: ANDA077908
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 0409-4699-24 00409469924 10 VIAL in 1 TRAY (0409-4699-24) / 100 mL in 1 VIAL (0409-4699-54) 10 vial 2006-04-03 0000-00-00 No No Current 0409-4699-30 00409469930 5 VIAL in 1 CARTON (0409-4699-30) > 20 mL in 1 VIAL (0409-4699-50) 5 vial 2006-04-04 0000-00-00 No No Current 0409-4699-33 00409469933 20 VIAL in 1 TRAY (0409-4699-33) / 50 mL in 1 VIAL (0409-4699-53) 20 vial 2006-04-03 0000-00-00 No No Current 0409-4699-50 00409469950 20 mL in 1 VIAL 20 ml Historical 0409-4699-53 00409469953 50 mL in 1 VIAL 50 ml Historical 0409-4699-54 00409469954 100 mL in 1 VIAL 100 ml Historical