FDA.reportPublic FDA data

Acetaminophen

Product NDC
76420-914
11-digit product format
764200914
Labeler code
76420
Product ID
76420-914_2ef14964-4fa1-9fb6-e063-6294a90aff36
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen tablet extended release
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA215486
Marketing category
ANDA
Marketing start
2021-10-04
Substance
ACETAMINOPHEN
Active strength
650 mg/1
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
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

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
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
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
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product 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
76420-914-01Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
76420-914-05Acetaminophen50 in 1 CARTONTABLET, EXTENDED RELEASE502
76420-914-05Acetaminophen1 in 1 BOTTLETABLET, EXTENDED RELEASE12
76420-914-26Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2252
76420-914-40Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4002
76420-914-42Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE242
76420-914-42Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE12
76420-914-60Acetaminophen60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-914-01EA - Each76420-91492b7e6de-1e98-43f7-812e-87fd3f5c3b2012025-07-08
76420-914-05EA - Each76420-91433ff1f01-a8fe-41dc-84f0-1252e980536112025-07-08
76420-914-26EA - Each76420-91449b8b977-285e-4551-9402-4066271cb17412025-07-08
76420-914-40EA - Each76420-91416675aaf-0f63-43d1-9657-9b5e625ea74f12025-07-08
76420-914-42EA - Each76420-914ca0742f2-4420-4078-9e60-9faf67d0fc5012025-07-08
76420-914-60EA - Each76420-91411addeee-98ff-4849-ab7d-37b1c26c14ca12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-914ACETAMINOPHEN (ACETAMINOPHEN TABLET EXTENDED RELEASE) TABLET, EXTENDED RELEASE [ASCLEMED USA, INC.]2Current NDC, 8 package rows20250227_4ef6bc2b-03cf-474f-bb9e-dbb5792ec197.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN4ef6bc2b-03cf-474f-bb9e-dbb5792ec1972
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD4ef6bc2b-03cf-474f-bb9e-dbb5792ec1972
11483998 HR APAP 650 MG Extended Release Oral TabletSY4ef6bc2b-03cf-474f-bb9e-dbb5792ec1972
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY4ef6bc2b-03cf-474f-bb9e-dbb5792ec1972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-914-0176420091401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01) 2025-01-27NoNoHistorical
76420-914-057642009140550 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE50 bottle2025-01-27NoNoHistorical
76420-914-2676420091426225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26) 2025-01-25NoNoHistorical
76420-914-4076420091440400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40) 2025-01-27NoNoHistorical
76420-914-42764200914421 BOTTLE in 1 CARTON (76420-914-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2025-01-27NoNoHistorical
76420-914-607642009146060 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60) 2025-02-25NoNoHistorical