major acetaminophen

Product NDC: 0904-6883
11-digit product format: 009046883
Labeler code: 0904
Product ID: 0904-6883_94ba0748-82d5-434b-8a2d-b4d7cc6b98ac
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA075077
Marketing category: ANDA
Marketing start: 2019-03-04
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075077-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2000-02-25

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: major acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ca9e1dae-eefb-4653-952f-2fde09059693	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6883-65	major acetaminophen	400 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	400		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6883-65	EA - Each	0904-6883	229d5bf3-734c-4c65-8e0e-27a9d4943590	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6883	MAJOR ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 1 package rows	20221111_ca9e1dae-eefb-4653-952f-2fde09059693.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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
arthritis pain relief	ACETAMINOPHEN	Publix Super Markets Inc	af407852-5476-421d-a80a-d726c24b6391	2025-05-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
arthritis pain reliever	ACETAMINOPHEN	Walgreen Company	5028c116-d0e3-4e30-8fa8-caaf08d99ec7	2025-05-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Pain Relief 8 HR	ACETAMINOPHEN	H E B	b5c7e93b-e626-49c3-a7d4-773475f945ae	2022-11-12	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
arthritis pain relief	ACETAMINOPHEN	Meijer Distribution Inc	c388f3a5-03bb-4fed-b81a-bb876bc260f0	2022-10-27	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Pain Relief	ACETAMINOPHEN	Meijer Distribution Inc	bfe37210-b322-4edb-8ff2-aff9b3e66be0	2022-10-27	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Equate 8HR Arthritis Pain Relief	ACETAMINOPHEN	Wal-Mart Stores Inc	ca7f0f68-2862-4265-bf4a-3a89994b4d6b	2022-10-13	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
topcare 8 hr arthritis pain relief	ACETAMINOPHEN	Topco Associates LLC	0d427360-ff9d-4e98-b218-6eb6c015dc6a	2022-05-23	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	2022-03-23	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN	ca9e1dae-eefb-4653-952f-2fde09059693	3
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	ca9e1dae-eefb-4653-952f-2fde09059693	3
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	ca9e1dae-eefb-4653-952f-2fde09059693	3
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	ca9e1dae-eefb-4653-952f-2fde09059693	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6883-65	00904688365	400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0904-6883-65)	2019-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Acetaminophen Extended-Release Tablets, 650 mg Drug Facts	Major Pharmaceuticals	2026-08-27	HUMAN OTC DRUG LABEL	4