FDA.reportPublic FDA data

HEB

Product NDC
37808-120
11-digit product format
378080120
Labeler code
37808
Product ID
37808-120_f924d0ab-cfa6-7dbe-e053-6394a90abc40
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
HEB
Application
ANDA211544
Marketing category
ANDA
Marketing start
2020-03-01
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
HEB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-120-02HEB50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE503
37808-120-02HEB1 in 1 CARTONTABLET, EXTENDED RELEASE13
37808-120-04HEB100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-120HEB (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [HEB]3Current NDC, Legacy NDC, 3 package rows20230413_96b1808f-defa-28cb-e053-2995a90a563b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN96b1808f-defa-28cb-e053-2995a90a563b3
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD96b1808f-defa-28cb-e053-2995a90a563b3
11483998 HR APAP 650 MG Extended Release Oral TabletSY96b1808f-defa-28cb-e053-2995a90a563b3
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY96b1808f-defa-28cb-e053-2995a90a563b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-120-02378080120021 BOTTLE, PLASTIC in 1 CARTON (37808-120-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2020-08-010000-00-00NoNoCurrent
37808-120-0437808012004100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (37808-120-04) 2020-03-010000-00-00NoNoCurrent