Home NDC 16714-977 propofol
Product NDC 16714-977
11-digit product format 167140977
Labeler code 16714
Product ID 16714-977_d7b2f7ed-e91e-430a-bab2-a9533b90e8b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name propofol
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler NorthStar Rx LLC
Application ANDA206408
Marketing category ANDA
Marketing start 2022-07-01
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 A206408-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206408-001 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 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206408-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2021-10-12 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 16714-977-01 propofol 50 mL in 1 VIAL INJECTION, EMULSION 50 5 16714-977-20 propofol 20 in 1 CARTON INJECTION, EMULSION 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-977 PROPOFOL INJECTION, EMULSION [NORTHSTAR RX LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241207_5ec25932-6c21-4cd5-8f60-80761f2e20a6.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 · 3 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 16714-977-01 16714097701 50 mL in 1 VIAL 50 ml Historical 16714-977-20 16714097720 20 VIAL in 1 CARTON (16714-977-20) / 50 mL in 1 VIAL (16714-977-01) 20 vial 2025-06-02 0000-00-00 No No Current