Tramadol Hydrochloride and Acetaminophen

Product NDC: 65162-617
11-digit product format: 651620617
Labeler code: 65162
Product ID: 65162-617_6319fa30-73b8-4d71-913f-416910ce4b5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA090485
Marketing category: ANDA
Marketing start: 2009-12-17
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength: 325 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2024-12-31
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
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
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
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
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
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
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
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
9457302e-0ca3-d9ff-0863-1b24b6107218	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
d5c49867-1fe9-7a44-3319-814417011d51	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
65162-617-10	EA - Each	65162-617	d8c536ee-b532-48cc-98a4-7e69ad819b36	1	2012-07-24
65162-617-11	EA - Each	65162-617	ffe68a8e-a3d2-43a6-a95f-4ea6eeb1a0e5	1	2012-07-24
65162-617-50	EA - Each	65162-617	eeaf296b-e461-4ba9-9843-ca424ab23c17	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	1001
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	8
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	3
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [RXCHANGE CO.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	28f41a8b-d23d-4c6b-9c0e-340a338a86da	1002
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	28f41a8b-d23d-4c6b-9c0e-340a338a86da	1002
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	28f41a8b-d23d-4c6b-9c0e-340a338a86da	1002
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	8a6e1be7-35af-4cab-99d9-4360ff48bf06	9
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	8a6e1be7-35af-4cab-99d9-4360ff48bf06	9
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	8a6e1be7-35af-4cab-99d9-4360ff48bf06	9
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	76444c7e-ff07-4032-92fe-dd8a2208ab55	3
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	7613ef1c-9cdb-41aa-99f9-2355851f74a6	3
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	76444c7e-ff07-4032-92fe-dd8a2208ab55	3
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	7613ef1c-9cdb-41aa-99f9-2355851f74a6	3
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	7613ef1c-9cdb-41aa-99f9-2355851f74a6	3
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	76444c7e-ff07-4032-92fe-dd8a2208ab55	3
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	45190f26-d4cc-4cac-86b4-f79ea3b88fa2	2
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	45190f26-d4cc-4cac-86b4-f79ea3b88fa2	2
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	45190f26-d4cc-4cac-86b4-f79ea3b88fa2	2
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	6ddf4f5b-b6bb-4a15-a621-cd327d27ec53	1
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	a1ddeea2-763e-4c37-a9f8-b57906c80a28	1
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	c547dd64-5339-4b34-934d-dd7d63989172	1
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	6ddf4f5b-b6bb-4a15-a621-cd327d27ec53	1
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	a1ddeea2-763e-4c37-a9f8-b57906c80a28	1
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	c547dd64-5339-4b34-934d-dd7d63989172	1
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	6ddf4f5b-b6bb-4a15-a621-cd327d27ec53	1
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	a1ddeea2-763e-4c37-a9f8-b57906c80a28	1
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	c547dd64-5339-4b34-934d-dd7d63989172	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-617-03	65162061703	30 TABLET in 1 BOTTLE (65162-617-03)	30 tablet	2009-12-17	0000-00-00	No	No	Current
65162-617-10	65162061710	100 TABLET in 1 BOTTLE (65162-617-10)	100 tablet	2009-12-17	0000-00-00	No	No	Current
65162-617-11	65162061711	1000 TABLET in 1 BOTTLE (65162-617-11)	1000 tablet	2009-12-17	0000-00-00	No	No	Current
65162-617-50	65162061750	500 TABLET in 1 BOTTLE (65162-617-50)	500 tablet	2009-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride and Acetaminophen	Bryant Ranch Prepack	2022-02-15	HUMAN PRESCRIPTION DRUG LABEL	1002
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
Tramadol Hydrochloride and Acetaminophen Tablets, USP CIV	Preferred Pharmaceuticals, Inc.	2016-09-19	HUMAN PRESCRIPTION DRUG LABEL	9
Tramadol Hydrochloride and Acetaminophen Tablets, USP CIV	RxChange Co.	2014-11-20	HUMAN PRESCRIPTION DRUG LABEL	1
Tramadol Hydrochloride and Acetaminophen Tablets, USP	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2014-10-28	HUMAN PRESCRIPTION DRUG LABEL	1
Tramadol Hydrochloride and Acetaminophen Tablets, USP	Aidarex Pharmaceuticals LLC	2012-10-05	HUMAN PRESCRIPTION DRUG LABEL	3
Rx only	H.J. Harkins Company, Inc. \| Sun Pharmaceutical Industries, Ltd.	2012-04-19	Human Prescription Drug Label	2
Tramadol Hydrochloride and Acetaminophen Tablets	Rebel Distributors Corp	2011-12-20	HUMAN PRESCRIPTION DRUG LABEL	1

Tramadol Hydrochloride and Acetaminophen

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#