FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
62207-183
11-digit product format
622070183
Labeler code
62207
Product ID
62207-183_3b99409a-218c-06ee-e063-6394a90aace0
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules India Limited
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-04-18
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
ndc (product): 62207-183
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
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
2027-12-31

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
00eb3e4b-1507-4c9a-83a5-ef50cb312753Available on FDA.report

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
62207-183-34ACETAMINOPHEN1 in 1 BOXTABLET, EXTENDED RELEASE110
62207-183-34ACETAMINOPHEN5 in 1 POUCHTABLET, EXTENDED RELEASE510
62207-183-35ACETAMINOPHEN3000 in 1 POUCHTABLET, EXTENDED RELEASE300010
62207-183-35ACETAMINOPHEN6 in 1 BOXTABLET, EXTENDED RELEASE610
62207-183-49ACETAMINOPHEN1000 in 1 BOTTLETABLET, EXTENDED RELEASE100010
62207-183-51ACETAMINOPHEN1 in 1 CARTONTABLET, EXTENDED RELEASE110
62207-183-51ACETAMINOPHEN10 in 1 BOTTLETABLET, EXTENDED RELEASE1010
62207-183-87ACETAMINOPHEN1 in 1 POUCHTABLET, EXTENDED RELEASE110
62207-183-87ACETAMINOPHEN1 in 1 BOXTABLET, EXTENDED RELEASE110
62207-183-97ACETAMINOPHEN40000 in 1 DRUMTABLET, EXTENDED RELEASE4000010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-183ACETAMINOPHEN TABLET, EXTENDED RELEASE [GRANULES INDIA LIMITED]9Current NDC, Legacy NDC, 10 package rows20230505_00eb3e4b-1507-4c9a-83a5-ef50cb312753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN00eb3e4b-1507-4c9a-83a5-ef50cb31275310
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD00eb3e4b-1507-4c9a-83a5-ef50cb31275310
11483998 HR APAP 650 MG Extended Release Oral TabletSY00eb3e4b-1507-4c9a-83a5-ef50cb31275310
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY00eb3e4b-1507-4c9a-83a5-ef50cb31275310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-183-34622070183341 POUCH in 1 BOX (62207-183-34) / 5 TABLET, EXTENDED RELEASE in 1 POUCH1 pouch2019-06-300000-00-00NoNoCurrent
62207-183-35622070183356 POUCH in 1 BOX (62207-183-35) / 3000 TABLET, EXTENDED RELEASE in 1 POUCH6 pouch2024-05-04NoNoCurrent
62207-183-49622070183491000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-183-49) 2019-04-180000-00-00NoNoCurrent
62207-183-51622070183511 BOTTLE in 1 CARTON (62207-183-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-04-180000-00-00NoNoCurrent
62207-183-87622070183871 POUCH in 1 BOX (62207-183-87) / 1 TABLET, EXTENDED RELEASE in 1 POUCH1 pouch2019-06-300000-00-00NoNoCurrent
62207-183-976220701839740000 TABLET, EXTENDED RELEASE in 1 DRUM (62207-183-97) 2021-03-250000-00-00NoNoCurrent