Ibuprofen

Product NDC: 53746-466
11-digit product format: 537460466
Labeler code: 53746
Product ID: 53746-466_769cfd1d-35d7-4f1a-ad8b-1bf642e02075
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA078558
Marketing category: ANDA
Marketing start: 2009-11-23
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
53746-466-01	Ibuprofen	100 in 1 BOTTLE	TABLET	100	26
53746-466-05	Ibuprofen	500 in 1 BOTTLE	TABLET	500	26
53746-466-30	Ibuprofen	30 in 1 BOTTLE	TABLET	30	26
53746-466-50	Ibuprofen	50 in 1 BOTTLE	TABLET	50	26
53746-466-60	Ibuprofen	60 in 1 BOTTLE	TABLET	60	26
53746-466-90	Ibuprofen	90 in 1 BOTTLE	TABLET	90	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-466-01	EA - Each	53746-466	28bf9c4e-100b-4f96-bbcf-5f7f814af3c8	1	2012-07-24
53746-466-05	EA - Each	53746-466	580cdb63-7daf-484f-8179-e63c91c8472f	1	2012-07-24
53746-466-90	EA - Each	53746-466	afd3f82a-ed47-47fb-8dfe-f4c3927ac977	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [BRYANT RANCH PREPACK]	1000
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [BRYANT RANCH PREPACK]	1000
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [MED HEALTH PHARMA, LLC]	8
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [MED HEALTH PHARMA, LLC]	8
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERAPROFEN-800 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PROFICIENT RX LP]	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PROFICIENT RX LP]	4
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [UNIT DOSE SERVICES]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [UNIT DOSE SERVICES]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [MEDVANTX, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [DIRECT RX]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [REBEL DISTRIBUTORS CORP]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [ALTURA PHARMACEUTICALS, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [RXCHANGE CO.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [MEDVANTX, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [DIRECT RX]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [ALTURA PHARMACEUTICALS, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [RXCHANGE CO.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [REBEL DISTRIBUTORS CORP]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-466	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	26	Current NDC, Legacy NDC, 6 package rows	20241222_faebc392-0fd9-4c71-8471-beba10dda022.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	e90c573d-eb0f-45a5-94d1-efdd3d2b7a11	1007
197807	ibuprofen 800 MG Oral Tablet	SCD	e90c573d-eb0f-45a5-94d1-efdd3d2b7a11	1007
197805	ibuprofen 400 MG Oral Tablet	PSN	faebc392-0fd9-4c71-8471-beba10dda022	26
197806	ibuprofen 600 MG Oral Tablet	PSN	faebc392-0fd9-4c71-8471-beba10dda022	26
197807	ibuprofen 800 MG Oral Tablet	PSN	faebc392-0fd9-4c71-8471-beba10dda022	26
197805	ibuprofen 400 MG Oral Tablet	SCD	faebc392-0fd9-4c71-8471-beba10dda022	26
197806	ibuprofen 600 MG Oral Tablet	SCD	faebc392-0fd9-4c71-8471-beba10dda022	26
197807	ibuprofen 800 MG Oral Tablet	SCD	faebc392-0fd9-4c71-8471-beba10dda022	26
197807	ibuprofen 800 MG Oral Tablet	PSN	69fbfd9b-5a75-486c-bf29-b63745cdfc7d	13
197807	ibuprofen 800 MG Oral Tablet	SCD	69fbfd9b-5a75-486c-bf29-b63745cdfc7d	13
197805	ibuprofen 400 MG Oral Tablet	PSN	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197806	ibuprofen 600 MG Oral Tablet	PSN	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197807	ibuprofen 800 MG Oral Tablet	PSN	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197805	ibuprofen 400 MG Oral Tablet	SCD	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197806	ibuprofen 600 MG Oral Tablet	SCD	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197807	ibuprofen 800 MG Oral Tablet	SCD	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197807	ibuprofen 800 MG Oral Tablet	PSN	912c536b-0d0c-4a9f-8778-c1534ceca658	8
197807	ibuprofen 800 MG Oral Tablet	SCD	912c536b-0d0c-4a9f-8778-c1534ceca658	8
197805	ibuprofen 400 MG Oral Tablet	PSN	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197806	ibuprofen 600 MG Oral Tablet	PSN	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197807	ibuprofen 800 MG Oral Tablet	PSN	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197807	ibuprofen 800 MG Oral Tablet	PSN	08570dbd-45f7-47d2-8b63-b4e63995e966	7
197805	ibuprofen 400 MG Oral Tablet	SCD	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197806	ibuprofen 600 MG Oral Tablet	SCD	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197807	ibuprofen 800 MG Oral Tablet	SCD	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197807	ibuprofen 800 MG Oral Tablet	SCD	08570dbd-45f7-47d2-8b63-b4e63995e966	7
197806	ibuprofen 600 MG Oral Tablet	PSN	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197807	ibuprofen 800 MG Oral Tablet	PSN	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197806	ibuprofen 600 MG Oral Tablet	SCD	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197807	ibuprofen 800 MG Oral Tablet	SCD	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197805	ibuprofen 400 MG Oral Tablet	PSN	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197806	ibuprofen 600 MG Oral Tablet	PSN	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197807	ibuprofen 800 MG Oral Tablet	PSN	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197805	ibuprofen 400 MG Oral Tablet	SCD	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197806	ibuprofen 600 MG Oral Tablet	SCD	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197807	ibuprofen 800 MG Oral Tablet	SCD	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197806	ibuprofen 600 MG Oral Tablet	PSN	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197807	ibuprofen 800 MG Oral Tablet	PSN	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197807	ibuprofen 800 MG Oral Tablet	PSN	05507c46-5292-43f1-bff7-5e1ee659ca3d	3
197806	ibuprofen 600 MG Oral Tablet	SCD	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197807	ibuprofen 800 MG Oral Tablet	SCD	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197807	ibuprofen 800 MG Oral Tablet	SCD	05507c46-5292-43f1-bff7-5e1ee659ca3d	3
197805	ibuprofen 400 MG Oral Tablet	PSN	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197805	ibuprofen 400 MG Oral Tablet	PSN	c22b75cb-c744-4233-bbf8-b220526daad8	2
197805	ibuprofen 400 MG Oral Tablet	PSN	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197805	ibuprofen 400 MG Oral Tablet	PSN	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197806	ibuprofen 600 MG Oral Tablet	PSN	c22b75cb-c744-4233-bbf8-b220526daad8	2
197806	ibuprofen 600 MG Oral Tablet	PSN	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197806	ibuprofen 600 MG Oral Tablet	PSN	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197806	ibuprofen 600 MG Oral Tablet	PSN	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197806	ibuprofen 600 MG Oral Tablet	PSN	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197807	ibuprofen 800 MG Oral Tablet	PSN	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197807	ibuprofen 800 MG Oral Tablet	PSN	1e50d4a4-8732-4e21-b7da-178961185021	2
197807	ibuprofen 800 MG Oral Tablet	PSN	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197807	ibuprofen 800 MG Oral Tablet	PSN	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197807	ibuprofen 800 MG Oral Tablet	PSN	c22b75cb-c744-4233-bbf8-b220526daad8	2
197807	ibuprofen 800 MG Oral Tablet	PSN	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197805	ibuprofen 400 MG Oral Tablet	SCD	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197805	ibuprofen 400 MG Oral Tablet	SCD	c22b75cb-c744-4233-bbf8-b220526daad8	2
197805	ibuprofen 400 MG Oral Tablet	SCD	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197805	ibuprofen 400 MG Oral Tablet	SCD	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197806	ibuprofen 600 MG Oral Tablet	SCD	c22b75cb-c744-4233-bbf8-b220526daad8	2
197806	ibuprofen 600 MG Oral Tablet	SCD	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197806	ibuprofen 600 MG Oral Tablet	SCD	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197806	ibuprofen 600 MG Oral Tablet	SCD	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197806	ibuprofen 600 MG Oral Tablet	SCD	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197807	ibuprofen 800 MG Oral Tablet	SCD	c22b75cb-c744-4233-bbf8-b220526daad8	2
197807	ibuprofen 800 MG Oral Tablet	SCD	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197807	ibuprofen 800 MG Oral Tablet	SCD	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197807	ibuprofen 800 MG Oral Tablet	SCD	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197807	ibuprofen 800 MG Oral Tablet	SCD	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197807	ibuprofen 800 MG Oral Tablet	SCD	1e50d4a4-8732-4e21-b7da-178961185021	2
197805	ibuprofen 400 MG Oral Tablet	PSN	c6c3b8b0-4932-4cee-af0b-f14425925c50	1
197805	ibuprofen 400 MG Oral Tablet	PSN	940f3140-fe00-4297-ba81-f49bc3a3ace0	1
197806	ibuprofen 600 MG Oral Tablet	PSN	c6c3b8b0-4932-4cee-af0b-f14425925c50	1
197806	ibuprofen 600 MG Oral Tablet	PSN	940f3140-fe00-4297-ba81-f49bc3a3ace0	1
197807	ibuprofen 800 MG Oral Tablet	PSN	5ace2a78-fb10-a635-e053-2991aa0a4ad2	1
197807	ibuprofen 800 MG Oral Tablet	PSN	7b0f3f87-751a-4cc3-9b9a-95bedfd7c5e0	1
197807	ibuprofen 800 MG Oral Tablet	PSN	fd620691-719e-46c9-aa78-47c7151dbeec	1
197807	ibuprofen 800 MG Oral Tablet	PSN	913ac1a0-ce4f-48af-a033-9d06e37c20de	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-466-01	53746046601	100 TABLET in 1 BOTTLE (53746-466-01)	100 tablet	2009-11-23	0000-00-00	No	No	Current
53746-466-05	53746046605	500 TABLET in 1 BOTTLE (53746-466-05)	500 tablet	2009-11-23	0000-00-00	No	No	Current
53746-466-30	53746046630	30 TABLET in 1 BOTTLE (53746-466-30)	30 tablet	2009-11-23	0000-00-00	No	No	Current
53746-466-50	53746046650	50 TABLET in 1 BOTTLE (53746-466-50)	50 tablet	2009-11-23	0000-00-00	No	No	Current
53746-466-60	53746046660	60 TABLET in 1 BOTTLE (53746-466-60)	60 tablet	2009-11-23	0000-00-00	No	No	Current
53746-466-90	53746046690	90 TABLET in 1 BOTTLE (53746-466-90)	90 tablet	2009-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals, LLC	2024-07-29	HUMAN PRESCRIPTION DRUG LABEL	26
Ibuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only	Bryant Ranch Prepack	2024-01-16	HUMAN PRESCRIPTION DRUG LABEL	1007
Ibuprofen Tablets, USP RX Only	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	9
Ibuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only	Aphena Pharma Solutions - Tennessee, Inc.	2019-12-26	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP RX Only	QPharma Inc \| Amneal Pharmaceuticals of New York, LLC \| Denton Pharma, Inc.	2019-11-13	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP RX Only	Unit Dose Services	2017-11-13	HUMAN PRESCRIPTION DRUG LABEL	13
313 Ibuprofen 800 mg Ibuprofen Tablets, USP RX Only	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-10-05	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP RX Only	Preferred Pharmaceuticals, Inc.	2017-01-26	HUMAN PRESCRIPTION DRUG LABEL	4
IBUPROFEN	Direct Rx	2016-05-31	HUMAN PRESCRIPTION DRUG LABEL	7
Ibuprofen Tablets, USP RX Only	Blenheim Pharmacal, Inc.	2015-03-01	HUMAN PRESCRIPTION DRUG LABEL	3
Ibuprofen Tablets, USP RX Only	RxChange Co. \| Amneal Pharmaceuticals of New York, LLC	2014-11-09	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-02	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP	Med Health Pharma, LLC	2012-09-06	HUMAN PRESCRIPTION DRUG LABEL	8
Ibuprofen Tablets, USP	Aidarex Pharmaceuticals LLC	2012-09-06	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP	Medsource Pharmaceuticals	2012-07-24	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP	STAT Rx USA LLC \| PSS World Medical Inc.	2012-02-08	HUMAN PRESCRIPTION DRUG LABEL	5
Ibuprofen Tablets, USP	Life Line Home Care Services, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP	Rebel Distributors Corp	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP	H.J. Harkins Company, Inc. \| Amneal Pharmaceuticals	2011-12-08	HUMAN PRESCRIPTION DRUG LABEL	2
Theraprofen-800	Physician Therapeutics LLC \| Amneal Pharmaceuticals \| H.J. Harkins Company, Inc \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	7
Ibuprofen Tablets, USP	RedPharm Drug Inc. \| Amneal Pharmaceuticals	2011-07-26	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP	Keltman Pharmaceuticals Inc.	2011-01-03	HUMAN PRESCRIPTION DRUG LABEL	3
Ibuprofen Tablets, USP	Physicians Total Care, Inc.	2010-09-17	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP	MedVantx, Inc. \| Amneal Pharmaceuticals \| Blenheim Pharmacal, Inc.	2010-09-17	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP	Altura Pharmaceuticals, Inc.	2010-04-28	HUMAN PRESCRIPTION DRUG LABEL	1

Ibuprofen

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