Ibuprofen

Product NDC: 21695-066
11-digit product format: 216950066
Labeler code: 21695
Product ID: 21695-066_79505457-733c-4253-ac74-fa864b1a9e55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075682
Marketing category: ANDA
Marketing start: 2009-06-10
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 400 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-066-20	2019-09-24	C162847	48780-1	934fe258-4b7b-48b1-e053-8cdaa90a720a	Ibuprofen Tablets, USP
21695-066-30	2019-09-24	C162847	48780-1	934fe258-4b7b-48b1-e053-8cdaa90a720a	Ibuprofen Tablets, USP
21695-066-40	2019-09-24	C162847	48780-1	934fe258-4b7b-48b1-e053-8cdaa90a720a	Ibuprofen Tablets, USP
21695-066-90	2019-09-24	C162847	48780-1	934fe258-4b7b-48b1-e053-8cdaa90a720a	Ibuprofen Tablets, USP

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-066-20	Ibuprofen	20 in 1 BOTTLE	TABLET, FILM COATED	20	2
21695-066-30	Ibuprofen	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
21695-066-40	Ibuprofen	40 in 1 BOTTLE	TABLET, FILM COATED	40	2
21695-066-90	Ibuprofen	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-066-20	EA - Each	21695-066	2026fec9-daa7-4a9e-a90b-9cf8a8c76c44	1	2012-07-24
21695-066-30	EA - Each	21695-066	cda15c9d-4b51-4b3a-a276-1edb9a87fa18	1	2012-07-24
21695-066-40	EA - Each	21695-066	1265565f-30bc-4bed-a79e-0af1d03d58d1	1	2012-07-24
21695-066-90	EA - Each	21695-066	ed7d5d3e-60db-46b8-ac16-f1d1be1d9365	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-066	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 4 package rows	20091120_c9ccbafa-99de-49f0-9946-3877bfdc3d7c.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197805	ibuprofen 400 MG Oral Tablet	PSN	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
197806	ibuprofen 600 MG Oral Tablet	PSN	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
197807	ibuprofen 800 MG Oral Tablet	PSN	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
197805	ibuprofen 400 MG Oral Tablet	SCD	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
197806	ibuprofen 600 MG Oral Tablet	SCD	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
197807	ibuprofen 800 MG Oral Tablet	SCD	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-066-20	21695006620	20 in 1 BOTTLE	Historical
21695-066-30	21695006630	30 in 1 BOTTLE	Historical
21695-066-40	21695006640	40 in 1 BOTTLE	Historical
21695-066-90	21695006690	90 in 1 BOTTLE	Historical