Acetaminophen

Product NDC: 55579-405
Requested package NDC: 55579-405-24
11-digit product format: 555790405
Labeler code: 55579
Product ID: 55579-405_d92bd5a7-d41c-31d1-e053-2995a90a143a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Solupharm Pharmazeutische Erzeugnisse GmbH
Application: ANDA202605
Marketing category: ANDA
Marketing start: 2020-12-07
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 · 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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A202605-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-06-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202605-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-06-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202605-001	AP1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202605-001	AP1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202605-001	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202605-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202605-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202605-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202605-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202605-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202605-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202605-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202605-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202605-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202605-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202605-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202605-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202605-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202605-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202605-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202605-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202605-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202605-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202605-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202605-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202605-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202605-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202605-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202605-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202605-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202605-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202605-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202605-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202605-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202605-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202605-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202605-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202605-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202605-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202605-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202605-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202605-001	AP	1	`cb3db0bc1861…`

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
d92be8ae-3173-0a9d-e053-2995a90abc63	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55579-405-24	Acetaminophen	100 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	100		1
55579-405-24	Acetaminophen	24 in 1 CARTON	INJECTION, SOLUTION	24		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55579-405	ACETAMINOPHEN INJECTION, SOLUTION [SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH]	1	Current NDC, Legacy NDC, 2 package rows	20220302_d92be8ae-3173-0a9d-e053-2995a90abc63.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Hikma Pharmaceuticals USA Inc.	7243bf2c-2c44-4dff-8a9e-d788d31dca86	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202605 application number: ANDA202605
Acetaminophen	ACETAMINOPHEN	Solupharm Pharmazeutische Erzeugnisse GmbH	adeebc6c-c82f-40dc-b813-1b02244984ce	2023-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202605 application number: ANDA202605
Acetaminophen	ACETAMINOPHEN	Hikma Pharmaceuticals USA Inc.	b466c989-f7aa-e476-e053-2a95a90a8e55	2022-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202605 application number: ANDA202605
Acetaminophen	ACETAMINOPHEN	Solupharm Pharmazeutische Erzeugnisse GmbH	d92be8ae-3173-0a9d-e053-2995a90abc63	2022-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202605 application number: ANDA202605 ndc (package): 55579-405-24 ndc (product): 55579-405 ndc11 (package): 55579040524

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	d92be8ae-3173-0a9d-e053-2995a90abc63	1
483017	100 ML acetaminophen 10 MG/ML Injection	SCD	d92be8ae-3173-0a9d-e053-2995a90abc63	1
483017	100 ML APAP 10 MG/ML Injection	SY	d92be8ae-3173-0a9d-e053-2995a90abc63	1
483017	acetaminophen 1000 MG per 100 ML Injection	SY	d92be8ae-3173-0a9d-e053-2995a90abc63	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55579-405-24	55579040524	24 VIAL, GLASS in 1 CARTON (55579-405-24) / 100 mL in 1 VIAL, GLASS	2020-12-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen	Solupharm Pharmazeutische Erzeugnisse GmbH	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL	1