Application 016030

Type: NDA
Sponsor: BAYER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	8-HOUR BAYER	ASPIRIN	TABLET, EXTENDED RELEASE;ORAL	650MG	No	No
002	MEASURIN	ASPIRIN	TABLET, EXTENDED RELEASE;ORAL	650MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016030-001	8-HOUR BAYER	ASPIRIN	650MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982
N016030-002	MEASURIN	ASPIRIN	650MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3a93d1ddd44b…`

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 18 · 350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Low Dose Aspirin	ASPIRIN	Strategic Sourcing Services LLC	7ce4807e-7bd5-41f1-a9c7-1f3af6acdc09	2026-09-09	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regular Strength	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	2777beea-06d7-4ff5-ae4a-ad7a117dfb62	2026-09-02	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Chewable Aspirin	ASPIRIN	Farmacias De Similares TX LLC	513ea306-74c6-96e3-e063-6394a90a8262	2026-09-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	HAWAII REPACK, INC.	ac94cce3-9a39-41de-bb8b-10a5e5b8e83b	2026-08-28	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	WinCo Foods, LLC	a0a19cd1-eb8a-4773-be00-78de90d2a3c3	2026-08-28	Warnings	Name fallback generic name: ASPIRIN
equate aspirin	ASPIRIN	Wal-Mart Stores Inc	ea3f8eed-7b70-4156-9586-125d27bf29a8	2026-08-19	Warnings	Name fallback generic name: ASPIRIN
aspirin chewable, low dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	6a6ac7fe-91a4-4b55-979a-b53b51505d8b	2026-08-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg	ASPIRIN	HARRIS TEETER	54e69d5a-55d7-4ebe-8494-0be93613f1e2	2026-08-12	Warnings	Name fallback generic name: ASPIRIN
Chewable Aspirin	ASPIRIN	HARRIS TEETER	c6a28c83-60c9-3304-e053-2a95a90aa06c	2026-08-12	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	HARRIS TEETER	93cbd3cb-1072-89e6-e053-2995a90a2f15	2026-08-12	Warnings	Name fallback generic name: ASPIRIN
Adult Chewable Aspirin	ASPIRIN	HARRIS TEETER	c6a28617-1769-7a7d-e053-2995a90a1ea0	2026-08-12	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	Amazon.com Services LLC	c7cc0681-4c0b-4565-99df-d0168c8ba1ba	2026-08-10	Warnings	Name fallback generic name: ASPIRIN
Gencare-Aspirin Low Dose Pain reliever (NSAID)	ASPIRIN	Pioneer Life Sciences, LLC	24d4f46a-c7a5-4e94-804f-1e307d8e8cfc	2026-08-09	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	DOLGENCORP, LLC	b4064039-2345-4227-b83d-54dc13a838d3	2026-08-07	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	87def9e0-0246-42cf-b8ea-2513d52e9f68	2026-08-07	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	P & L Development, LLC	4cd74cec-a209-4e92-b853-fbe5c95f7678	2026-08-06	Warnings	Name fallback generic name: ASPIRIN
pain relief aspirin Low Dose	ASPIRIN	Rite Aid Corporation	df7835c9-f10f-40c6-8955-61423d94b677	2026-08-05	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	DOLGENCORP, LLC	7396c97e-8a51-4a21-8208-f13258b5285c	2026-08-05	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	3ba0a9f2-062a-401e-82eb-54383a822366	2026-07-29	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric Coated	ASPIRIN	Cardinal Health 107, LLC	277723db-3578-4842-92eb-2de325f87649	2026-07-28	Warnings	Name fallback generic name: ASPIRIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.