Medline

Product NDC: 53329-221
11-digit product format: 533290221
Labeler code: 53329
Product ID: 53329-221_52f7367f-6ed1-700e-e063-6294a90a3eaa
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Medline Industries, LP
Application: ANDA075077
Marketing category: ANDA
Marketing start: 2026-08-28
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: Medline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53329-221-09	53329022109	1 BOTTLE in 1 CARTON (53329-221-09) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (53329-221-29)	1 bottle	2026-08-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
221 Acetaminophen 650MG Tablets, Extended Release	Medline Industries, LP	2026-08-28	HUMAN OTC DRUG LABEL	1