Home NDC 63323-434 Acetaminophen
Product NDC 63323-434
11-digit product format 633230434
Labeler code 63323
Product ID 63323-434_be958bb9-95c1-4525-a145-f1372f08f978
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA204767
Marketing category NDA
Marketing start 2020-12-06
Substance ACETAMINOPHEN
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N204767-001 ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204767-001 8741959 2030-04-19 Drug product 2019-09-24
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 · 44 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 2026-10-15 13:18:30 2026-09 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204767-001 ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION / INTRAVENOUS 2015-10-28 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204767-001 8741959 2030-04-19 Drug product 2019-09-24 e64feba35796…
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 2027-12-31 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 63323-434-00 Acetaminophen 20 in 1 CASE INJECTION 20 5 63323-434-41 Acetaminophen 100 mL in 1 BAG INJECTION 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-434 ACETAMINOPHEN INJECTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240427_a0cece43-256e-4adc-92f8-11a0f473bb83.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 63323-434-00 63323043400 20 BAG in 1 CASE (63323-434-00) / 100 mL in 1 BAG (63323-434-41) 20 bag 2020-12-06 0000-00-00 No No Current 63323-434-41 63323043441 100 mL in 1 BAG 100 ml Historical