Home NDC 43598-548 Propofol Injectable Emulsion
Product NDC 43598-548
11-digit product format 435980548
Labeler code 43598
Product ID 43598-548_b4a9147e-dfe3-229a-d8d7-6a84e6449f15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propofol Injectable Emulsion
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Dr. Reddy's Laboratories, Inc.
Application ANDA205067
Marketing category ANDA
Marketing start 2018-11-15
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 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 A205067-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205067-001 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 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205067-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2018-11-15 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 Injectable Emulsion
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 43598-548-21 Propofol Injectable Emulsion 20 in 1 CARTON INJECTION, EMULSION 20 5 43598-548-50 Propofol Injectable Emulsion 50 mL in 1 VIAL INJECTION, EMULSION 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-548 PROPOFOL INJECTABLE EMULSION INJECTION, EMULSION [DR. REDDY'S LABORATORIES, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20230401_800646b8-83a8-01d9-3dc8-bb2ddcb8570c.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 · 1 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 43598-548-21 43598054821 20 VIAL in 1 CARTON (43598-548-21) / 50 mL in 1 VIAL (43598-548-50) 20 vial 2018-11-15 0000-00-00 No No Current 43598-548-50 43598054850 50 mL in 1 VIAL 50 ml Historical