FDA.reportPublic FDA data

Acetaminophen

Product NDC
58602-730
11-digit product format
586020730
Labeler code
58602
Product ID
58602-730_462dae43-f3b8-4f6c-846b-de19a01d169c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA207229
Marketing category
ANDA
Marketing start
2016-11-09
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
58602-730-07Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE249
58602-730-07Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-14Acetaminophen50 in 1 BOTTLETABLET, EXTENDED RELEASE509
58602-730-14Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-21Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-21Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
58602-730-28Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-28Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2259
58602-730-29Acetaminophen150 in 1 BOTTLETABLET, EXTENDED RELEASE1509
58602-730-34Acetaminophen200 in 1 BOTTLETABLET, EXTENDED RELEASE2009
58602-730-35Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2259
58602-730-36Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-36Acetaminophen250 in 1 BOTTLETABLET, EXTENDED RELEASE2509
58602-730-40Acetaminophen500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
58602-730-41Acetaminophen1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009
58602-730-44Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4009
58602-730-67Acetaminophen290 in 1 BOTTLETABLET, EXTENDED RELEASE2909
58602-730-76Acetaminophen325 in 1 BOTTLETABLET, EXTENDED RELEASE3259
58602-730-94Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-730-94EA - Each58602-7307ab748be-d1a1-4866-ae62-6ce6c0b6d4b912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-730ACETAMINOPHEN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]9Current NDC, Legacy NDC, 19 package rows20240126_179c221d-c099-400c-b3ac-124e26947620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN179c221d-c099-400c-b3ac-124e269476209
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD179c221d-c099-400c-b3ac-124e269476209
11483998 HR APAP 650 MG Extended Release Oral TabletSY179c221d-c099-400c-b3ac-124e269476209
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY179c221d-c099-400c-b3ac-124e269476209

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-730-07586020730071 BOTTLE in 1 CARTON (58602-730-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-08-110000-00-00NoNoCurrent
58602-730-14586020730141 BOTTLE in 1 CARTON (58602-730-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-08-110000-00-00NoNoCurrent
58602-730-21586020730211 BOTTLE in 1 CARTON (58602-730-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-08-110000-00-00NoNoCurrent
58602-730-28586020730281 BOTTLE in 1 CARTON (58602-730-28) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent
58602-730-2958602073029150 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-29) 2018-08-110000-00-00NoNoCurrent
58602-730-3458602073034200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-34) 2018-08-110000-00-00NoNoCurrent
58602-730-3558602073035225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-35) 2018-08-110000-00-00NoNoCurrent
58602-730-36586020730361 BOTTLE in 1 CARTON (58602-730-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2016-11-090000-00-00NoNoCurrent
58602-730-4058602073040500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-40) 2018-08-110000-00-00NoNoCurrent
58602-730-41586020730411000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-41) 2018-08-110000-00-00NoNoCurrent
58602-730-4458602073044400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-44) 2021-01-110000-00-00NoNoCurrent
58602-730-6758602073067290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-67) 2018-08-110000-00-00NoNoCurrent
58602-730-7658602073076325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-76) 2018-08-110000-00-00NoNoCurrent
58602-730-9458602073094100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-94) 2020-04-080000-00-00NoNoCurrent