IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

Manufacturer: A-S Medication Solutions
Effective date: 2021-05-18
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:36:51

Label at a glance#

ProductIBUPROFEN

Active ingredientIBUPROFEN

Label structure3 sections

Label contents#

Full prescribing information#

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

SPL MEDGUIDE SECTION

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5159

NDC: 50090-5159-2 28 TABLET, FILM COATED in a BOTTLE

NDC: 50090-5159-0 90 TABLET, FILM COATED in a BOTTLE

IBUPROFEN TABLET, FILM COATED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197805	ibuprofen 400 MG Oral Tablet	PSN	3
197805	ibuprofen 400 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5159-0	2023-01-30	C162847	48780-1	f386c649-fb4c-0266-e053-dadaa90a7c1a	IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
50090-5159-2	2023-01-30	C162847	48780-1	f386c649-fb4c-0266-e053-dadaa90a7c1a	IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5159-0	IBUPROFEN	90 in 1 BOTTLE	TABLET, FILM COATED	90		3
50090-5159-2	IBUPROFEN	28 in 1 BOTTLE	TABLET, FILM COATED	28		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5159	IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20210602_03c44243-c1f5-4e0d-8cf8-dfda03cfbb5d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-602-01	EA - Each	49483-602	2fcf2aef-f364-4616-9d83-3fd90e8572d1	1	2016-01-13
49483-602-50	EA - Each	49483-602	047d18b6-f1fd-488e-89cf-926de1700cd4	1	2016-01-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

IBUPROFEN
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-5159	50090-5159-0, 50090-5159-2
49483-602

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN	WK2XYI10QM	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090796-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21
A090796-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21
A090796-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090796-001	AB
A090796-002	AB
A090796-003	AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090796-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090796-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090796-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090796-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090796-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090796-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-001	AB	1	`301d65b070ca…`

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	TIME CAP LABORATORIES, INC	ec3e8443-d742-4c25-8516-f0df4ebfccdc	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 49483-602
88589883-b891-41e8-9cb8-dcb0dec16b28			03c44243-c1f5-4e0d-8cf8-dfda03cfbb5d	2021-05-18		Exact identifier spl id: 88589883-b891-41e8-9cb8-dcb0dec16b28 spl set id: 03c44243-c1f5-4e0d-8cf8-dfda03cfbb5d

Reported adverse events (FAERS/openFDA)#

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