Topcare Ibuprofen

Product NDC: 36800-074
11-digit product format: 368000074
Labeler code: 36800
Product ID: 36800-074_c2b22cd7-e373-4773-97ad-3108ef71be01
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA077349
Marketing category: ANDA
Marketing start: 2006-04-10
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-074		D	Discontinued by firm	2026-10-05
excluded package	package	36800-074	36800-074-71	D	Discontinued by firm	2026-10-05
excluded package	package	36800-074	36800-074-78	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-074-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-074-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-074-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-074-78	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A077349-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL		RS	2005-06-21

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-074-71	EA - Each	36800-074	c8ec80aa-eb56-411f-9270-a0affd5564de	1	2012-07-24
36800-074-78	EA - Each	36800-074	25e08e7a-93fc-487c-abbc-e4365d2eda43	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	2

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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen 200mg	IBUPROFEN 200MG	Allegiant Health	51e95588-39af-40d6-9924-e98d42af15b9	2018-12-31	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-074-71	36800007471	1 BOTTLE in 1 CARTON (36800-074-71) > 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2006-04-10	0000-00-00	No	No	Current
36800-074-78	36800007478	1 BOTTLE in 1 CARTON (36800-074-78) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2006-06-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Ibuprofen Tablets 200 mg Drug Facts	Topco Associates LLC	2022-03-23	HUMAN OTC DRUG LABEL	5