FDA.reportPublic FDA data

Acetaminophen

Product NDC
24201-100
11-digit product format
242010100
Labeler code
24201
Product ID
24201-100_802892dd-9061-400e-b20d-d7a005b3877f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA202605
Marketing category
ANDA
Marketing start
2023-03-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202605-001ACETAMINOPHENACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12016-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202605-001AP1

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202605-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12016-06-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202605-001AP11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENHikma Pharmaceuticals USA Inc.7243bf2c-2c44-4dff-8a9e-d788d31dca862026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202605
application number: ANDA202605
AcetaminophenACETAMINOPHENSolupharm Pharmazeutische Erzeugnisse GmbHadeebc6c-c82f-40dc-b813-1b02244984ce2023-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202605
application number: ANDA202605
AcetaminophenACETAMINOPHENHikma Pharmaceuticals USA Inc.b466c989-f7aa-e476-e053-2a95a90a8e552022-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202605
application number: ANDA202605
ndc (product): 24201-100
AcetaminophenACETAMINOPHENSolupharm Pharmazeutische Erzeugnisse GmbHd92be8ae-3173-0a9d-e053-2995a90abc632022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202605
application number: ANDA202605

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483017Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b466c989-f7aa-e476-e053-2a95a90a8e55Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24201-100-24Acetaminophen100 mL in 1 VIAL, GLASSINJECTION, SOLUTION1009
24201-100-24Acetaminophen24 in 1 CARTONINJECTION, SOLUTION249

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24201-100-24ML - Milliliter24201-100489f9acf-ec10-45fb-b393-4059bb572f3e12021-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSNb466c989-f7aa-e476-e053-2a95a90a8e559
483017100 ML acetaminophen 10 MG/ML InjectionSCDb466c989-f7aa-e476-e053-2a95a90a8e559
483017100 ML APAP 10 MG/ML InjectionSYb466c989-f7aa-e476-e053-2a95a90a8e559
483017acetaminophen 1000 MG per 100 ML InjectionSYb466c989-f7aa-e476-e053-2a95a90a8e559

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24201-100-242420101002424 VIAL, GLASS in 1 CARTON (24201-100-24) / 100 mL in 1 VIAL, GLASS2023-03-010000-00-00NoNoCurrent