FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
13107-059
11-digit product format
131070059
Labeler code
13107
Product ID
13107-059_d0765823-c018-4aae-85e9-27288fe43950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA202800
Marketing category
ANDA
Marketing start
2013-04-15
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 30 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15
A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15
A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202800-001AA
A202800-002AA
A202800-003AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15a50c72e98297…
2026-08-01 22:54:322026-06A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15a50c72e98297…
2026-08-01 22:54:322026-06A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202800-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A202800-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A202800-003AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAurolife Pharma, LLC02386806-02d4-47e3-9c8b-7810146ee7952025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
ndc (product): 13107-059
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack30da1bea-2dbc-4086-a5cf-8ed471bb65932024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack9f2127d9-d60b-42d3-9b6c-798e63dd68d12024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.8f12016d-904f-00b4-e053-2a95a90ad02a2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.80c9a58d-98ae-5497-e053-2991aa0a61fb2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.7d69403e-90d0-7a80-e053-2a91aa0a55522024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP75b50751-5237-4e3e-b7ee-1605c0602f3b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Codeine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
CODEINE PHOSPHATE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
GSL05Y1MN6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993770Internal RxNorm lookup
993781Internal RxNorm lookup
993890Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02386806-02d4-47e3-9c8b-7810146ee795Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-059-01Acetaminophen and Codeine Phosphate100 in 1 BOTTLETABLET10023
13107-059-05Acetaminophen and Codeine Phosphate500 in 1 BOTTLETABLET50023
13107-059-30Acetaminophen and Codeine Phosphate30 in 1 BOTTLETABLET3023
13107-059-99Acetaminophen and Codeine Phosphate1000 in 1 BOTTLETABLET100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-059-01EA - Each13107-059ef9f3134-9459-4ee4-818c-98c4364c954712014-01-04
13107-059-99EA - Each13107-0597eb21515-74f5-487c-9f53-ed250b27524612014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]4
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-059ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC]21Current NDC, Legacy NDC, 4 package rows20240726_02386806-02d4-47e3-9c8b-7810146ee795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993770codeine phosphate 15 MG / acetaminophen 300 MG Oral TabletPSN02386806-02d4-47e3-9c8b-7810146ee79523
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN02386806-02d4-47e3-9c8b-7810146ee79523
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN02386806-02d4-47e3-9c8b-7810146ee79523
993770acetaminophen 300 MG / codeine phosphate 15 MG Oral TabletSCD02386806-02d4-47e3-9c8b-7810146ee79523
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD02386806-02d4-47e3-9c8b-7810146ee79523
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD02386806-02d4-47e3-9c8b-7810146ee79523
993770APAP 300 MG / codeine phosphate 15 MG Oral TabletSY02386806-02d4-47e3-9c8b-7810146ee79523
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY02386806-02d4-47e3-9c8b-7810146ee79523
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY02386806-02d4-47e3-9c8b-7810146ee79523
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN30da1bea-2dbc-4086-a5cf-8ed471bb65938
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD30da1bea-2dbc-4086-a5cf-8ed471bb65938
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY30da1bea-2dbc-4086-a5cf-8ed471bb65938
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN50e8fd6f-8cde-4c61-e054-00144ff88e887
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN7d69403e-90d0-7a80-e053-2a91aa0a55527
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD50e8fd6f-8cde-4c61-e054-00144ff88e887
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD7d69403e-90d0-7a80-e053-2a91aa0a55527
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY50e8fd6f-8cde-4c61-e054-00144ff88e887
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY7d69403e-90d0-7a80-e053-2a91aa0a55527
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN75b50751-5237-4e3e-b7ee-1605c0602f3b6
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD75b50751-5237-4e3e-b7ee-1605c0602f3b6
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY75b50751-5237-4e3e-b7ee-1605c0602f3b6
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8f12016d-904f-00b4-e053-2a95a90ad02a4
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8f12016d-904f-00b4-e053-2a95a90ad02a4
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8f12016d-904f-00b4-e053-2a95a90ad02a4
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN57fa21c1-20f7-7eee-e053-2991aa0a7d7e2
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8d80d5fd-7863-c551-e053-2995a90af2a92
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN8d812c2b-15a6-4b6d-e053-2a95a90a889a2
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN486aa4c5-d307-48e7-e054-00144ff88e882
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD57fa21c1-20f7-7eee-e053-2991aa0a7d7e2
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8d80d5fd-7863-c551-e053-2995a90af2a92
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8d812c2b-15a6-4b6d-e053-2a95a90a889a2
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD486aa4c5-d307-48e7-e054-00144ff88e882
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY57fa21c1-20f7-7eee-e053-2991aa0a7d7e2
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8d80d5fd-7863-c551-e053-2995a90af2a92
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8d812c2b-15a6-4b6d-e053-2a95a90a889a2
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY486aa4c5-d307-48e7-e054-00144ff88e882
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN71c7a685-c60a-d801-e053-2a95a90aec5f1
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD71c7a685-c60a-d801-e053-2a95a90aec5f1
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY71c7a685-c60a-d801-e053-2a95a90aec5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-059-0113107005901100 TABLET in 1 BOTTLE (13107-059-01) 100 tablet2013-04-150000-00-00NoNoCurrent
13107-059-0513107005905500 TABLET in 1 BOTTLE (13107-059-05) 500 tablet2013-04-150000-00-00NoNoCurrent
13107-059-301310700593030 TABLET in 1 BOTTLE (13107-059-30) 30 tablet2013-04-150000-00-00NoNoCurrent
13107-059-99131070059991000 TABLET in 1 BOTTLE (13107-059-99) 1000 tablet2013-04-150000-00-00NoNoCurrent