Ibuprofen

Product NDC: 63548-0185
Requested package NDC: 63548-0185-3
11-digit product format: 635480185
Labeler code: 63548
Product ID: 63548-0185_b60654de-0ca8-46e1-9094-bb59bff2b1f4
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application: ANDA076460
Marketing category: ANDA
Marketing start: 2013-08-01
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: 2027-12-31
Current FDA listing: Yes

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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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
A076460-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2003-11-26

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	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`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: Ibuprofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63548-0185-1	2023-02-09	DRUG FACTS
63548-0185-1	2023-02-09	DRUG FACTS
63548-0185-2	2023-02-09	DRUG FACTS
63548-0185-2	2023-02-09	DRUG FACTS
63548-0185-3	2023-02-09	DRUG FACTS
63548-0185-3	2023-02-09	DRUG FACTS
63548-0185-1	2023-01-30	DRUG FACTS
63548-0185-1	2023-01-30	DRUG FACTS
63548-0185-2	2023-01-30	DRUG FACTS
63548-0185-2	2023-01-30	DRUG FACTS
63548-0185-3	2023-01-30	DRUG FACTS
63548-0185-3	2023-01-30	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63548-0185-1	Ibuprofen	10 in 1 VIAL	TABLET, COATED	10	5
63548-0185-2	Ibuprofen	1 in 1 BOX	TABLET, COATED	1	5
63548-0185-2	Ibuprofen	100 in 1 BOTTLE	TABLET, COATED	100	5
63548-0185-3	Ibuprofen	1000 in 1 BOTTLE	TABLET, COATED	1000	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63548-0185	IBUPROFEN TABLET, COATED [PLD ACQUISITIONS LLC DBA AV&EACUTE;MA PHARMA SOLUTIONS]	5	Current NDC, Legacy NDC, 4 package rows	20250130_c6dcc329-bab5-41ab-94e7-625e07628fd6.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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	c6dcc329-bab5-41ab-94e7-625e07628fd6	2025-01-28	Warnings	Exact identifier application applno (ANDA): 076460 application number: ANDA076460 ndc (package): 63548-0185-3 ndc (product): 63548-0185 ndc11 (package): 63548018503
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	1662a495-4f6a-4515-a405-557681e1a496	2023-02-09	Warnings	Exact identifier application applno (ANDA): 076460 application number: ANDA076460

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	c6dcc329-bab5-41ab-94e7-625e07628fd6	5
310965	ibuprofen 200 MG Oral Tablet	SCD	c6dcc329-bab5-41ab-94e7-625e07628fd6	5
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	c6dcc329-bab5-41ab-94e7-625e07628fd6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63548-0185-3	63548018503	1000 TABLET, COATED in 1 BOTTLE (63548-0185-3)	2013-08-01	0000-00-00	No	No	Current