Acetaminophen

Product NDC
30142-968
11-digit product format
301420968
Labeler code
30142
Product ID
30142-968_02638c5b-50c5-4b54-bbf8-6427f298b88a
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
The Kroger Company
Application
ANDA076200
Marketing category
ANDA
Marketing start
2021-02-19
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct30142-968DDiscontinued by firm2026-08-03
excluded packagepackage30142-96830142-968-01DDiscontinued by firm2026-08-03

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
A076200-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19cb3db0bc1861…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-968ACETAMINOPHEN TABLET, EXTENDED RELEASE [THE KROGER COMPANY]5Legacy NDC20250114_e2b402d7-0f68-49a0-b68a-f3e359efc780.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENMedline Industries, LP9f18d455-55ce-482c-8da8-dcb664038c6c2026-04-10WarningsExact identifier
application applno (ANDA): 076200
application number: ANDA076200

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-968-01301420968011 BOTTLE in 1 CARTON (30142-968-01) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-02-190000-00-00NoNoCurrent