FDA.reportPublic FDA data

Acetaminophen

Product NDC
69848-015
Requested package NDC
69848-015-10
11-digit product format
698480015
Labeler code
69848
Product ID
69848-015_4690a42a-ee23-e19b-e063-6294a90a2d9f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Granules USA, Inc.
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-12-31
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211544-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16

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
2026-08-01 22:54:322026-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8 HR Arthritis PainACETAMINOPHENDr. Reddy's Laboratories Inc.8e780c23-997c-b960-226e-954037baad4b2026-07-01WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ACETAMINOPHENACETAMINOPHENGranules India Limited00eb3e4b-1507-4c9a-83a5-ef50cb3127532026-06-15WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
Arthritis PainACETAMINOPHENGrocery Outlet, Inc.441d0aa0-9a65-98e9-e063-6294a90a5eb22026-05-21WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ACETAMINOPHENACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labsa3217b48-7482-4cc7-8811-ae75fd9d78052026-02-26WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENCVS PHARMACY INCbd8ce39f-ccf8-3976-e053-2a95a90abb1f2025-12-23WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENGranules USA, Inc.96131c7b-bdff-0642-e053-2a95a90a4f322025-12-22WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (package): 69848-015-10
ndc (product): 69848-015
ndc11 (package): 69848001510
AcetaminophenACETAMINOPHENWAL-MART STORES INC940936ac-e59f-7489-e053-2a95a90a63642025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENWAL-MART STORES INCe34d07b5-ccbb-cd14-e053-2a95a90a394b2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INCed23c587-7806-1f64-e053-2a95a90aea7f2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENMEIJER, INC.ed25620f-e39b-e30c-e053-2995a90af6212025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a0fb0afe-9c25-d0f6-e053-2995a90adbba2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a56791ec-0037-51a3-e053-2995a90af7612025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENWALGREENS8f8d43d1-8e73-483e-e053-2a95a90ac99b2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENWALGREENS CO.8dba6ae0-1bfb-84de-e053-2a95a90aae462025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Incf797848e-f23f-997b-e053-6394a90aae552025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENMAJOR PHARMACEUTICALSefd0a432-abbb-1f88-e053-2995a90a8ce52025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Incf5dc335d-d3cf-ba94-e053-2a95a90ac6d32025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENSAM'S WEST INCe77c2bc7-0258-4a6d-e053-2a95a90afe6e2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENCVS PHARMACY iNC90cea23f-5ddb-7a36-e053-2a95a90a20cf2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENWalgreens0944a5d4-2ccc-5f0d-e063-6394a90a8af92025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1148399Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
96131c7b-bdff-0642-e053-2a95a90a4f32Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69848-015-102020-12-30C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
69848-015-102020-09-27C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
69848-015-102020-09-25C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
69848-015-102020-07-22C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-015-10Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1009
69848-015-24Acetaminophen24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE249

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69848-015-10EA - Each69848-01562184175-7742-4377-bc10-d0028f27e01d12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69848-015ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [GRANULES USA, INC. ]8Current NDC, Legacy NDC, 2 package rows20241212_96131c7b-bdff-0642-e053-2a95a90a4f32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN96131c7b-bdff-0642-e053-2a95a90a4f329
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD96131c7b-bdff-0642-e053-2a95a90a4f329
11483998 HR APAP 650 MG Extended Release Oral TabletSY96131c7b-bdff-0642-e053-2a95a90a4f329
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY96131c7b-bdff-0642-e053-2a95a90a4f329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69848-015-1069848001510100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10) 2019-12-310000-00-00NoNoCurrent