Ibuprofen

Product NDC: 49483-604
11-digit product format: 494830604
Labeler code: 49483
Product ID: 49483-604_27b8b074-c62d-7214-e063-6294a90adb69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC
Application: ANDA090796
Marketing category: ANDA
Marketing start: 2015-12-30
Substance: IBUPROFEN
Active strength: 800 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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	800 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	WK2XYI10QM
Rxcui	197805, 197806, 197807

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-604-01	Ibuprofen	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
49483-604-03	Ibuprofen	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
49483-604-05	Ibuprofen	50 in 1 BOTTLE	TABLET, FILM COATED	50	8
49483-604-50	Ibuprofen	500 in 1 BOTTLE	TABLET, FILM COATED	500	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-604-01	EA - Each	49483-604	4c978774-cbdd-4eda-a974-dfea4b1a3110	1	2016-01-13
49483-604-50	EA - Each	49483-604	3bc46c7c-6ff6-423b-9ef0-88aec4a6d297	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-604	IBUPROFEN TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	8	Current NDC, Legacy NDC, 4 package rows	20241130_ec3e8443-d742-4c25-8516-f0df4ebfccdc.zip

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
197807	ibuprofen 800 MG Oral Tablet	PSN	7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb	15
197807	ibuprofen 800 MG Oral Tablet	SCD	7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb	15
197806	ibuprofen 600 MG Oral Tablet	PSN	c3f30813-0848-6e8a-e053-2995a90a3dea	11
197807	ibuprofen 800 MG Oral Tablet	PSN	c3f30813-0848-6e8a-e053-2995a90a3dea	11
197806	ibuprofen 600 MG Oral Tablet	SCD	c3f30813-0848-6e8a-e053-2995a90a3dea	11
197807	ibuprofen 800 MG Oral Tablet	SCD	c3f30813-0848-6e8a-e053-2995a90a3dea	11
197807	ibuprofen 800 MG Oral Tablet	PSN	b33caad1-8d40-16f2-e053-2a95a90a1b2d	10
197807	ibuprofen 800 MG Oral Tablet	SCD	b33caad1-8d40-16f2-e053-2a95a90a1b2d	10
197805	ibuprofen 400 MG Oral Tablet	PSN	ec3e8443-d742-4c25-8516-f0df4ebfccdc	8
197806	ibuprofen 600 MG Oral Tablet	PSN	ec3e8443-d742-4c25-8516-f0df4ebfccdc	8
197807	ibuprofen 800 MG Oral Tablet	PSN	ec3e8443-d742-4c25-8516-f0df4ebfccdc	8
197805	ibuprofen 400 MG Oral Tablet	SCD	ec3e8443-d742-4c25-8516-f0df4ebfccdc	8
197806	ibuprofen 600 MG Oral Tablet	SCD	ec3e8443-d742-4c25-8516-f0df4ebfccdc	8
197807	ibuprofen 800 MG Oral Tablet	SCD	ec3e8443-d742-4c25-8516-f0df4ebfccdc	8
197807	ibuprofen 800 MG Oral Tablet	PSN	950c3ca7-4481-976f-e053-2995a90ad51e	7
197807	ibuprofen 800 MG Oral Tablet	SCD	950c3ca7-4481-976f-e053-2995a90ad51e	7
197807	ibuprofen 800 MG Oral Tablet	PSN	9b02607a-6fab-5205-e053-2a95a90afa26	6
197807	ibuprofen 800 MG Oral Tablet	PSN	553c8cfa-cf0f-0b1f-e054-00144ff88e88	6
197807	ibuprofen 800 MG Oral Tablet	SCD	553c8cfa-cf0f-0b1f-e054-00144ff88e88	6
197807	ibuprofen 800 MG Oral Tablet	SCD	9b02607a-6fab-5205-e053-2a95a90afa26	6
197807	ibuprofen 800 MG Oral Tablet	PSN	a2f3b793-171c-2bde-e053-2995a90a62a0	5
197807	ibuprofen 800 MG Oral Tablet	SCD	a2f3b793-171c-2bde-e053-2995a90a62a0	5
197805	ibuprofen 400 MG Oral Tablet	PSN	6d189e86-4c36-43f5-b406-a342458d4155	4
197806	ibuprofen 600 MG Oral Tablet	PSN	6d189e86-4c36-43f5-b406-a342458d4155	4
197807	ibuprofen 800 MG Oral Tablet	PSN	f18b6a0a-e42f-083d-e053-2995a90a40e4	4
197807	ibuprofen 800 MG Oral Tablet	PSN	c20f1f4d-59b3-6bbe-e053-2a95a90abaf1	4
197807	ibuprofen 800 MG Oral Tablet	PSN	6d189e86-4c36-43f5-b406-a342458d4155	4
197805	ibuprofen 400 MG Oral Tablet	SCD	6d189e86-4c36-43f5-b406-a342458d4155	4
197806	ibuprofen 600 MG Oral Tablet	SCD	6d189e86-4c36-43f5-b406-a342458d4155	4
197807	ibuprofen 800 MG Oral Tablet	SCD	f18b6a0a-e42f-083d-e053-2995a90a40e4	4
197807	ibuprofen 800 MG Oral Tablet	SCD	c20f1f4d-59b3-6bbe-e053-2a95a90abaf1	4
197807	ibuprofen 800 MG Oral Tablet	SCD	6d189e86-4c36-43f5-b406-a342458d4155	4
197807	ibuprofen 800 MG Oral Tablet	PSN	99d7cf65-3ec2-24eb-e053-2a95a90acc5e	3
197807	ibuprofen 800 MG Oral Tablet	SCD	99d7cf65-3ec2-24eb-e053-2a95a90acc5e	3
197807	ibuprofen 800 MG Oral Tablet	PSN	ca1e0d03-cbb3-4899-b196-0eee09c511a2	2
197807	ibuprofen 800 MG Oral Tablet	SCD	ca1e0d03-cbb3-4899-b196-0eee09c511a2	2
197807	ibuprofen 800 MG Oral Tablet	PSN	9add412e-3494-4097-e053-2995a90a8fc7	1
197807	ibuprofen 800 MG Oral Tablet	PSN	7cb00cc2-20af-428c-8290-9b5bf0aec68d	1
197807	ibuprofen 800 MG Oral Tablet	PSN	b510fd71-351b-4e4c-bb04-ee52c52cb423	1
197807	ibuprofen 800 MG Oral Tablet	SCD	7cb00cc2-20af-428c-8290-9b5bf0aec68d	1
197807	ibuprofen 800 MG Oral Tablet	SCD	b510fd71-351b-4e4c-bb04-ee52c52cb423	1
197807	ibuprofen 800 MG Oral Tablet	SCD	9add412e-3494-4097-e053-2995a90a8fc7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-604-01	49483060401	100 TABLET, FILM COATED in 1 BOTTLE (49483-604-01)	2015-12-30	0000-00-00	No	No	Current
49483-604-03	49483060403	30 TABLET, FILM COATED in 1 BOTTLE (49483-604-03)	2015-12-30	0000-00-00	No	No	Current
49483-604-05	49483060405	50 TABLET, FILM COATED in 1 BOTTLE (49483-604-05)	2015-12-30	0000-00-00	No	No	Current
49483-604-50	49483060450	500 TABLET, FILM COATED in 1 BOTTLE (49483-604-50)	2015-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS	St. Mary's Medical Park Pharmacy	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	7
IBUPROFEN 800 MG TABLETS	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
IBUPROFEN	DIRECT RX	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	11
IBUPROFEN 800 MG TABLETS	PD-Rx Pharmaceuticals, Inc.	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	15
IBUPROFEN 800 MG TABLETS	PD-Rx Pharmaceuticals, Inc.	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	24
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS	NuCare Pharmaceuticals,Inc.	2025-01-02	HUMAN PRESCRIPTION DRUG LABEL	6
Ibuprofen Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	10
Ibuprofen Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	4
IBUPROFEN 400 MG, 600 MG AND 800 MG TABLETS	TIME CAP LABORATORIES, INC \| MARKSANS PHARMA LIMITED	2024-11-21	HUMAN PRESCRIPTION DRUG LABEL	8
IBUPROFEN 800mg	RedPharm Drug, Inc.	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	5
IBUPROFEN - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	6
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS	RPK Pharmaceuticals, Inc.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	2
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS	UNIT DOSE SERVICES	2023-06-28	HUMAN PRESCRIPTION DRUG LABEL	1
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS	Bryant Ranch Prepack	2020-05-27	HUMAN PRESCRIPTION DRUG LABEL	4
IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS	Aphena Pharma Solutions - Tennessee, LLC	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	1
IBUPROFEN 800 MG TABLETS	medsource pharmaceuticals \| TIME CAP LABORATORIES, INC	2019-12-29	HUMAN PRESCRIPTION DRUG LABEL	1

Ibuprofen

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#