Home NDC 55150-307 Acetaminophen
Product NDC 55150-307
11-digit product format 551500307
Labeler code 55150
Product ID 55150-307_ddbd820d-6245-44a7-b539-3c6813ffa58a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA210969
Marketing category ANDA
Marketing start 2020-10-21
Substance ACETAMINOPHEN
Active strength 10 mg/mL
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 43 .
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 A210969-001 ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210969-001 AP1
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 2026-09-14 22:38:34 2026-08 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2020-10-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210969-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-10-21 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483017 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 55150-307-01 Acetaminophen 100 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 100 3 55150-307-24 Acetaminophen 24 in 1 CARTON INJECTION, SOLUTION 24 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-307 ACETAMINOPHEN INJECTION, SOLUTION [EUGIA US LLC] 3 Current NDC, Legacy NDC, 2 package rows 20230804_f80b6f72-f280-4b4a-a6a9-e6490b94705b.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 55150-307-01 55150030701 100 mL in 1 VIAL, SINGLE-DOSE 100 ml Historical 55150-307-24 55150030724 24 VIAL, SINGLE-DOSE in 1 CARTON (55150-307-24) / 100 mL in 1 VIAL, SINGLE-DOSE (55150-307-01) 2020-10-21 0000-00-00 No No Current