Acetaminophen

Product NDC: 0143-9386
11-digit product format: 001439386
Labeler code: 0143
Product ID: 0143-9386_e5ea1bad-d98b-475c-be6b-1d6415e3edff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA206968
Marketing category: NDA
Marketing start: 2022-06-03
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 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
N206968-001	ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-06-03

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206968-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-03	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88c29438-3648-4b09-bd43-70ad7a35bcb5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9386-01	Acetaminophen	100 mL in 1 BAG	INJECTION	100		6
0143-9386-10	Acetaminophen	10 in 1 CARTON	INJECTION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9386-01	ML - Milliliter	0143-9386	16e26c2b-d69d-46d8-88e4-bc00025437d9	1	2022-11-07
0143-9386-10	ML - Milliliter	0143-9386	def92a87-b025-4e7f-a34d-23a0ed9af723	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9386	ACETAMINOPHEN INJECTION [HIKMA PHARMACEUTICALS USA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240608_88c29438-3648-4b09-bd43-70ad7a35bcb5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Hikma Pharmaceuticals USA Inc.	88c29438-3648-4b09-bd43-70ad7a35bcb5	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206968 application number: NDA206968 ndc (product): 0143-9386

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	88c29438-3648-4b09-bd43-70ad7a35bcb5	6
483017	100 ML acetaminophen 10 MG/ML Injection	SCD	88c29438-3648-4b09-bd43-70ad7a35bcb5	6
483017	100 ML APAP 10 MG/ML Injection	SY	88c29438-3648-4b09-bd43-70ad7a35bcb5	6
483017	acetaminophen 1000 MG per 100 ML Injection	SY	88c29438-3648-4b09-bd43-70ad7a35bcb5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9386-01	00143938601	100 mL in 1 BAG	100 ml					Historical
0143-9386-10	00143938610	10 BAG in 1 CARTON (0143-9386-10) / 100 mL in 1 BAG (0143-9386-01)	10 bag	2022-06-03	0000-00-00	No	No	Current