Hydrocodone Bitartrate And Acetaminophen

Product NDC: 0603-3890
11-digit product format: 006033890
Labeler code: 0603
Product ID: 0603-3890_3916509c-21b4-4bcb-981e-40460abe7049
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate And Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA040655
Marketing category: ANDA
Marketing start: 2006-01-19
Marketing end: 2022-11-30
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
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
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
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
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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
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
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	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
0603-3890-02	EA - Each	0603-3890	f3e493a6-2ad0-4fd8-b088-8006039f9828	1	2012-07-24
0603-3890-04	EA - Each	0603-3890	fccbab6f-7c5c-48c9-aa5a-d00109d1b0ed	1	2012-07-24
0603-3890-16	EA - Each	0603-3890	8b77ab29-7c31-451a-9bbc-2363ea6f085a	1	2012-07-24
0603-3890-20	EA - Each	0603-3890	9f458962-5a50-43ba-9dcb-2f44a9d719af	1	2012-07-24
0603-3890-21	EA - Each	0603-3890	3357a964-c81c-41a3-a16e-bbbcd8b0c544	1	2012-07-24
0603-3890-22	EA - Each	0603-3890	190cda43-9660-4674-9fe7-e08ac0d24015	1	2012-07-24
0603-3890-28	EA - Each	0603-3890	f8e1a9be-b539-4e88-a5e8-94395b94d46d	1	2012-07-24
0603-3890-32	EA - Each	0603-3890	34dd3e04-ba88-4aab-b45c-e1f46c192414	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [DISPENSING SOLUTIONS, INC.]	4
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REDPHARM DRUG INC.]	3
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACETICALS]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	561043e9-3e09-4919-bf55-53907b3af9e5	10
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	561043e9-3e09-4919-bf55-53907b3af9e5	10
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	561043e9-3e09-4919-bf55-53907b3af9e5	10
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	3a1e0443-c06c-4945-8a9d-d6f764ca68a5	5
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	59e7db61-9ce5-416c-b576-87babe94dbdf	4
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	59e7db61-9ce5-416c-b576-87babe94dbdf	4
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	59e7db61-9ce5-416c-b576-87babe94dbdf	4
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	1e171e42-6083-4873-e054-00144ff88e88	3
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	c7a9280e-e713-4773-b4bd-aabec9cff63a	3
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	1e171e42-6083-4873-e054-00144ff88e88	3
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	c7a9280e-e713-4773-b4bd-aabec9cff63a	3
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	1e171e42-6083-4873-e054-00144ff88e88	3
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	1e171e42-6083-4873-e054-00144ff88e88	3
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	c7a9280e-e713-4773-b4bd-aabec9cff63a	3
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	1e171e42-6083-4873-e054-00144ff88e88	3
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	1e171e42-6083-4873-e054-00144ff88e88	3
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	2c17f3d1-2a00-45b1-82f3-420f778ee7c0	1
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	2c17f3d1-2a00-45b1-82f3-420f778ee7c0	1
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	2c17f3d1-2a00-45b1-82f3-420f778ee7c0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-3890-21	00603389021	100 TABLET in 1 BOTTLE, PLASTIC (0603-3890-21)	100 tablet	2006-01-19	2022-11-30	No	No	Current
0603-3890-28	00603389028	500 TABLET in 1 BOTTLE, PLASTIC (0603-3890-28)	500 tablet	2006-01-19	2022-11-30	No	No	Current
0603-3890-32	00603389032	1000 TABLET in 1 BOTTLE, PLASTIC (0603-3890-32)	1000 tablet	2006-01-19	2022-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate And Acetaminophen	A-S Medication Solutions	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	10
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx only	Medsource Pharmaceticals \| Medsource Pharmaceuticals	2018-12-27	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx only	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-23	HUMAN PRESCRIPTION DRUG LABEL	5
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only	Liberty Pharmaceuticals, Inc.	2013-09-06	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-10	HUMAN PRESCRIPTION DRUG LABEL	4
Hydrocodone Bitartrate & Acetaminophen Tablets	RedPharm Drug Inc. \| Vintage Pharmaceuticals, LLC	2011-06-02	HUMAN PRESCRIPTION DRUG LABEL	3

Hydrocodone Bitartrate And Acetaminophen

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#