Home NDC 84549-100 Acetaminophen
Product NDC 84549-100
11-digit product format 845490100
Labeler code 84549
Product ID 84549-100_3f7a6fdc-6e37-dc3e-e063-6394a90a067d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen
Dosage form INJECTION
Route INTRAVENOUS
Labeler ProPharma Distribution
Application NDA204957
Marketing category NDA
Marketing start 2021-02-18
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204957-001 ACETAMINOPHEN ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-02-18 N204957-002 ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2021-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 68 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 2026-02-19 14:30 UTC 2026-02 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2021-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2021-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 RLD, RS 2021-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204957-001 ACETAMINOPHEN 500MG/50ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204957-002 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-18 87673890dc5c…
Observed Orange Book normalized TE history# 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 84549-100-90 Acetaminophen 100 mL in 1 CONTAINER INJECTION 100 1
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 Sample Exclude flag Status 84549-100-90 84549010090 100 mL in 1 CONTAINER (84549-100-90) 100 ml 2025-09-23 No No Current