FDA.reportPublic FDA data

Acetaminophen

Product NDC
0264-4100
11-digit product format
002644100
Labeler code
0264
Product ID
0264-4100_011c0907-df72-4a78-9c37-0a65f9a48994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
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

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui483017, 2480095

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-4100-90Acetaminophen100 mL in 1 CONTAINERINJECTION10018
0264-4100-90Acetaminophen24 in 1 CASEINJECTION2418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-4100-90ML - Milliliter0264-4100af07394d-b98b-4629-9a56-da2632cf079c12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-4100ACETAMINOPHEN INJECTION [B. BRAUN MEDICAL INC.]18Current NDC, Legacy NDC, 2 package rows20230602_6d763554-913d-4bed-9efd-b9c9b936a2f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSN6d763554-913d-4bed-9efd-b9c9b936a2f418
2480095acetaminophen 500 MG in 50 ML InjectionPSN6d763554-913d-4bed-9efd-b9c9b936a2f418
483017100 ML acetaminophen 10 MG/ML InjectionSCD6d763554-913d-4bed-9efd-b9c9b936a2f418
248009550 ML acetaminophen 10 MG/ML InjectionSCD6d763554-913d-4bed-9efd-b9c9b936a2f418
483017100 ML APAP 10 MG/ML InjectionSY6d763554-913d-4bed-9efd-b9c9b936a2f418
248009550 ML APAP 10 MG/ML InjectionSY6d763554-913d-4bed-9efd-b9c9b936a2f418
483017acetaminophen 1000 MG per 100 ML InjectionSY6d763554-913d-4bed-9efd-b9c9b936a2f418
2480095acetaminophen 500 MG per 50 ML InjectionSY6d763554-913d-4bed-9efd-b9c9b936a2f418
483017acetaminophen 1000 MG in 100 ML InjectionPSN3f7a6fdc-6e36-dc3e-e063-6394a90a067d1
483017100 ML acetaminophen 10 MG/ML InjectionSCD3f7a6fdc-6e36-dc3e-e063-6394a90a067d1
483017100 ML APAP 10 MG/ML InjectionSY3f7a6fdc-6e36-dc3e-e063-6394a90a067d1
483017acetaminophen 1000 MG per 100 ML InjectionSY3f7a6fdc-6e36-dc3e-e063-6394a90a067d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-4100-900026441009024 CONTAINER in 1 CASE (0264-4100-90) / 100 mL in 1 CONTAINER24 container2021-02-180000-00-00NoNoCurrent
0264-4100-95002644100956 CARTON in 1 CASE (0264-4100-95) > 4 CONTAINER in 1 CARTON (0264-4100-90) > 100 mL in 1 CONTAINER6 carton2021-02-180000-00-00NoNoCurrent