ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC: 0406-0483
11-digit product format: 004060483
Labeler code: 0406
Product ID: 0406-0483_d718c5ef-69f7-4342-8ac6-772b45f6a726
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetaminophen and codeine phosphate
Dosage form: TABLET
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA040419
Marketing category: ANDA
Marketing start: 2001-05-31
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300; 15 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: ACETAMINOPHEN AND CODEINE PHOSPHATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	300 mg/1
CODEINE PHOSPHATE	15 mg/1

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
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
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
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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
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2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
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332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
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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
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c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0406-0483-01	ACETAMINOPHEN AND CODEINE PHOSPHATE	100 in 1 BOTTLE	TABLET	100		50

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-0483-01	EA - Each	0406-0483	a52ae884-c122-48a1-90b7-2e49b5d99258	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MALLINCKRODT, INC.]	17
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-0483	ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [SPECGX LLC]	48	Current NDC, Legacy NDC, 1 package rows	20250419_eadc80fa-13c3-471a-a22f-6fe7e1ab290f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	eadc80fa-13c3-471a-a22f-6fe7e1ab290f	50
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1	5
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993781	codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet	PSN	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993890	codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet	PSN	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993781	acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet	SCD	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993890	acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet	SCD	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993781	APAP 300 MG / codeine phosphate 30 MG Oral Tablet	SY	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993890	APAP 300 MG / codeine phosphate 60 MG Oral Tablet	SY	0332c7ca-7522-4fb5-96ea-2abe47322119	4
993770	codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet	PSN	5f1bf60d-62a2-437e-8273-5d699decd1ff	1
993770	acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet	SCD	5f1bf60d-62a2-437e-8273-5d699decd1ff	1
993770	APAP 300 MG / codeine phosphate 15 MG Oral Tablet	SY	5f1bf60d-62a2-437e-8273-5d699decd1ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-0483-01	00406048301	100 TABLET in 1 BOTTLE (0406-0483-01)	100 tablet	2001-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate Tablets USP CIII	SpecGx LLC	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	50
ACETAMINOPHEN AND CODEINE PHOSPHATE	Aphena Pharma Solutions - Tennessee, LLC	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	5
ACETAMINOPHEN AND CODEINE PHOSPHATE	Physicians Total Care, Inc.	2012-09-24	HUMAN PRESCRIPTION DRUG LABEL	4
ACETAMINOPHEN AND CODEINE PHOSPHATE	Dispensing Solutions, Inc.	2011-09-30	HUMAN PRESCRIPTION DRUG LABEL	1

ACETAMINOPHEN AND CODEINE PHOSPHATE

Additional Listing Data#

Active Ingredients#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#