ACETAMINOPHEN

Product NDC
51662-1540
Requested package NDC
51662-1540-1
11-digit product format
516621540
Labeler code
51662
Product ID
51662-1540_5c40c6f3-9a47-d3e9-e063-6294a90a685f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA210969
Marketing category
ANDA
Marketing start
2022-04-09
Substance
ACETAMINOPHEN
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210969-001ACETAMINOPHENACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210969-001AP1

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
2026-09-14 22:38:342026-08A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-10-2184e616aacf4f…
2026-08-18 06:07:402026-07A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-218869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP2020-10-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210969-001ACETAMINOPHEN1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-10-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210969-001AP1184e616aacf4f…
2026-08-18 06:07:402026-07A210969-001AP11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210969-001AP11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210969-001AP1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210969-001AP116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210969-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210969-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210969-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210969-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210969-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210969-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210969-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210969-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210969-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210969-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210969-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210969-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210969-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210969-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210969-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210969-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210969-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A210969-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210969-001AP18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210969-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210969-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210969-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210969-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210969-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210969-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210969-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210969-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210969-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210969-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210969-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210969-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210969-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210969-001AP11a50c72e98297…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN10 mg/mL

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
51662-1540-1ACETAMINOPHEN100 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1004
51662-1540-2ACETAMINOPHEN1 in 1 POUCHINJECTION, SOLUTION14
51662-1540-3ACETAMINOPHEN24 in 1 CASEINJECTION, SOLUTION244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1540ACETAMINOPHEN INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 3 package rows20240629_dc42ab17-cd30-4d1a-e053-2995a90a86ea.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210969
application number: ANDA210969
AcetaminophenACETAMINOPHENEugia US LLCf80b6f72-f280-4b4a-a6a9-e6490b94705b2023-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210969
application number: ANDA210969

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSNdc42ab17-cd30-4d1a-e053-2995a90a86ea4
483017100 ML acetaminophen 10 MG/ML InjectionSCDdc42ab17-cd30-4d1a-e053-2995a90a86ea4
483017100 ML APAP 10 MG/ML InjectionSYdc42ab17-cd30-4d1a-e053-2995a90a86ea4
483017acetaminophen 1000 MG per 100 ML InjectionSYdc42ab17-cd30-4d1a-e053-2995a90a86ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1540-151662154001100 mL in 1 VIAL, SINGLE-DOSE (51662-1540-1) 100 ml2022-04-090000-00-00NoNoCurrent