Acetaminophen

Product NDC: 84549-100
Requested package NDC: 84549-100-90
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 43.

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.

Application-product, TE code table
Application-product	TE code
N204957-001	AP
N204957-002	AP2

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 · 72 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	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2021-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204957-001	ACETAMINOPHEN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204957-002	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2021-02-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N204957-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204957-002	AP2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204957-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204957-002	AP2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204957-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204957-002	AP2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204957-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204957-002	AP2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204957-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204957-002	AP2	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204957-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204957-002	AP2	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3f7a6fdc-6e36-dc3e-e063-6394a90a067d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	ProPharma Distribution	3f7a6fdc-6e36-dc3e-e063-6394a90a067d	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204957 application number: NDA204957 ndc (package): 84549-100-90 ndc (product): 84549-100 ndc11 (package): 84549010090
Acetaminophen	ACETAMINOPHEN	B. Braun Medical Inc.	9744d804-2857-47ef-a27a-bca27db9394c	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204957 application number: NDA204957
Acetaminophen	ACETAMINOPHEN	B. Braun Medical Inc.	6d763554-913d-4bed-9efd-b9c9b936a2f4	2023-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204957 application number: NDA204957

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483017	acetaminophen 1000 MG in 100 ML Injection	PSN	3f7a6fdc-6e36-dc3e-e063-6394a90a067d	1
483017	100 ML acetaminophen 10 MG/ML Injection	SCD	3f7a6fdc-6e36-dc3e-e063-6394a90a067d	1
483017	100 ML APAP 10 MG/ML Injection	SY	3f7a6fdc-6e36-dc3e-e063-6394a90a067d	1
483017	acetaminophen 1000 MG per 100 ML Injection	SY	3f7a6fdc-6e36-dc3e-e063-6394a90a067d	1

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