Home NDC 67871-479 Ethamolin
Product NDC 67871-479
11-digit product format 678710479
Labeler code 67871
Product ID 67871-479_45a0d13c-0c73-6c2c-e063-6394a90aaa54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethanolamine Oleate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler QOL Medical, LLC.
Application NDA019357
Marketing category NDA
Marketing start 1998-12-22
Substance ETHANOLAMINE OLEATE
Active strength 50 mg/mL
Pharmacologic classes Sclerosing Activity [MoA], Sclerosing Agent [EPC], Vascular Sclerosing Activity [PE]
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 67871-479-06 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 67871-479-06 9bebd1f3094a…5416666fcb17…
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 N019357-001 ETHAMOLIN ETHANOLAMINE OLEATE 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22
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 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019357-001 ETHAMOLIN 50MG/ML INJECTABLE / INJECTION RLD, RS 1988-12-22 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Ethamolin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHANOLAMINE OLEATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U4RY8MRX7C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106675 Internal RxNorm lookup 205745 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67871-479-06 Ethamolin 10 in 1 BOX INJECTION, SOLUTION 10 14 67871-479-06 Ethamolin 2 mL in 1 AMPULE INJECTION, SOLUTION 2 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ethanolamine Oleate ACTIVE INGREDIENT U4RY8MRX7C ETHAMOLIN (ETHANOLAMINE OLEATE) INJECTION, SOLUTION [QOL MEDICAL, LLC.] 6 Ethanolamine ACTIVE MOIETY 5KV86114PT ETHAMOLIN (ETHANOLAMINE OLEATE) INJECTION, SOLUTION [QOL MEDICAL, LLC.] 6 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH ETHAMOLIN (ETHANOLAMINE OLEATE) INJECTION, SOLUTION [QOL MEDICAL, LLC.] 6 Water INACTIVE INGREDIENT 059QF0KO0R ETHAMOLIN (ETHANOLAMINE OLEATE) INJECTION, SOLUTION [QOL MEDICAL, LLC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67871-479 ETHAMOLIN (ETHANOLAMINE OLEATE) INJECTION, SOLUTION [QOL MEDICAL, LLC.] 12 Current NDC, Legacy NDC, 2 package rows 20241127_a9c1d8c5-443e-400e-a42c-16a25fb47231.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 67871-479-06 67871047906 10 AMPULE in 1 BOX (67871-479-06) / 2 mL in 1 AMPULE 10 ampule 1998-12-22 0000-00-00 No No Current