HYDROCODONE BITARTRATE AND IBUPROFEN

Product NDC: 62037-524
11-digit product format: 620370524
Labeler code: 62037
Product ID: 62037-524_e5666a18-5187-4405-b7c5-a45736cdedde
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE AND IBUPROFEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA076604
Marketing category: ANDA
Marketing start: 2004-04-01
Marketing end: 2019-09-30
Substance: HYDROCODONE BITARTRATE; IBUPROFEN
Active strength: 8 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
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
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62037-524-01	EA - Each	62037-524	5cce9578-cb74-43cc-9a5d-a63f304ee289	1	2012-07-24
62037-524-05	EA - Each	62037-524	9b45e006-5228-479f-983e-8beb327737d0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858798	HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	PSN	80140ebb-0d9c-4cab-bb8b-951849291b13	3
858798	hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	SCD	80140ebb-0d9c-4cab-bb8b-951849291b13	3
858798	HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	PSN	4fbc673b-546a-4845-e054-00144ff88e88	2
858798	hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	SCD	4fbc673b-546a-4845-e054-00144ff88e88	2
858798	HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	PSN	d86ced85-6767-4218-bf88-e294b44d1e74	1
858798	hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	SCD	d86ced85-6767-4218-bf88-e294b44d1e74	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCODONE BITARTRATE AND IBUPROFEN - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 mg/200 mg	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-23	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 mg/200 mg	Physicians Total Care, Inc.	2010-10-04	HUMAN PRESCRIPTION DRUG LABEL	1

HYDROCODONE BITARTRATE AND IBUPROFEN

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#