Acetaminophen

Product NDC
49035-350
11-digit product format
490350350
Labeler code
49035
Product ID
49035-350_4552c571-a168-4f8a-8d29-71ecfb575425
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores, Inc
Application
ANDA078569
Marketing category
ANDA
Marketing start
2013-08-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
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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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-350-082020-01-31C16284748780-19d75b9d0-9691-f424-e053-dadaa90a57ceDrug Facts
49035-350-202020-01-31C16284748780-19d75b9d0-9691-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-350-08Acetaminophen80 in 1 BOTTLETABLET, EXTENDED RELEASE801
49035-350-20Acetaminophen20 in 1 BOTTLETABLET, EXTENDED RELEASE201
49035-350-20Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-350ACETAMINOPHEN TABLET, EXTENDED RELEASE [WAL-MART STORES, INC]1Legacy NDC, 3 package rows20130805_3f2e66eb-9838-41e9-be12-a73bdeb8cfa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN3f2e66eb-9838-41e9-be12-a73bdeb8cfa51
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD3f2e66eb-9838-41e9-be12-a73bdeb8cfa51
11483998 HR APAP 650 MG Extended Release Oral TabletSY3f2e66eb-9838-41e9-be12-a73bdeb8cfa51
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY3f2e66eb-9838-41e9-be12-a73bdeb8cfa51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49035-350-084903503500880 in 1 BOTTLEHistorical
49035-350-204903503502020 in 1 BOTTLEHistorical