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 43.

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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
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…`

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 5 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Aspirin Low Dose	ASPIRIN	Rite Aid Corporation	503408ed-e799-48a0-8d38-3034f4a0ead5	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Lidl US LLC	468f4a2f-60f7-4808-95d7-a00be1bb112f	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	COSTCO WHOLESALE CORPORATION	c8a8986b-1ab4-9da0-71da-42595db08b44	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	318cc982-23a9-4804-b6fb-248f772d7a38	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Discount Drug Mart	4a1e9c79-5036-4c69-82f9-e48abc972b47	2026-04-02	Warnings	Name fallback generic name: ASPIRIN
Wispirin	ASPIRIN	Wisdrug AG	4e70ec5e-d033-a525-e063-6394a90a5a93	2026-04-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regimen	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	ef2d75ee-9ed7-4b53-adbc-2ec40364da63	2026-03-31	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	RMT HEALTH LLC	4dc7229d-c895-1f80-e063-6394a90abfc3	2026-03-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	d1f05e56-c830-4f85-b685-2a5965d10a1c	2026-03-26	Warnings	Name fallback generic name: ASPIRIN
aspirin	ASPIRIN	Meijer Distribution Inc	c550b92e-de54-4599-9534-bd3022b0a86d	2026-03-25	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	AmerisourceBergen (Good Neighbor Pharmacy) 46122	db187226-0770-4934-90a4-c6ca50bdecef	2026-03-25	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Aarkish Pharmaceuticals NJ Inc.	e5e9e1ce-666a-461f-8287-a4642902067c	2026-03-23	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Pain Reliever	ASPIRIN	TWIN MED LLC	a395acf4-f487-4c98-8c44-ca2aaaf72deb	2026-03-20	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN LOW DOSE	ASPIRIN	MAJOR PHARMACEUTICALS	7c24aff7-2b96-27ac-e053-2991aa0a5714	2026-03-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Chain Drug Marketing Association, Inc.	b32ada58-a098-47d2-9ed2-4d5918657709	2026-03-16	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Walgreen Company	413b3b95-2867-4534-8290-54f477cccf1e	2026-03-16	Warnings	Name fallback generic name: ASPIRIN
Aspirin Enteric Coated	ASPIRIN	CVS Pharmacy	c55304be-bfc0-46a8-a37e-2e6ba9098394	2026-03-12	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Preferred Pharmaceuticals Inc.	5e3633ff-64a4-4a72-addc-a3babea040b5	2026-03-09	Warnings	Name fallback generic name: ASPIRIN
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Preferred Pharmaceuticals Inc.	1b5b8bb1-c45d-48f0-b275-9ce1f769fed4	2026-03-09	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Preferred Pharmaceuticals Inc.	b0e260a2-4e86-479a-b17b-60324694f669	2026-03-09	Warnings	Name fallback generic name: ASPIRIN

Reported adverse events (FAERS/openFDA)#

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