Home NDC 55579-110 Acetaminophen
Product NDC 55579-110
11-digit product format 555790110
Labeler code 55579
Product ID 55579-110_f49c61bc-9a3e-d885-e053-2995a90ad8af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form INJECTION
Route INTRAVENOUS
Labeler Solupharm Pharmazeutische Erzeugnisse GmbH
Application ANDA202605
Marketing category ANDA
Marketing start 2020-12-07
Substance ACETAMINOPHEN
Active strength 1000 mg/100mL
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 A202605-001 ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2016-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202605-001 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.
Product history page 1 of 2 · 43 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 2026-09-14 22:38:34 2026-08 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2016-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2016-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2016-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2016-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2016-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202605-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2016-06-13 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 1000 mg/100mL
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 55579-110-01 Acetaminophen 100 mL in 1 BOTTLE INJECTION 100 1 55579-110-01 Acetaminophen 24 in 1 BOTTLE INJECTION 24 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55579-110 ACETAMINOPHEN INJECTION [SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH] 1 Current NDC, 2 package rows 20230214_adeebc6c-c82f-40dc-b813-1b02244984ce.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55579-110-01 55579011001 24 BOTTLE in 1 BOTTLE (55579-110-01) / 100 mL in 1 BOTTLE 24 bottle 2023-03-01 No No Current