FDA.reportPublic FDA data

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
68071-4533
Requested package NDC
68071-4533-5
11-digit product format
680714533
Labeler code
68071
Product ID
68071-4533_2d53b71b-7709-e12d-e063-6294a90a5478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040419
Marketing category
ANDA
Marketing start
2011-07-06
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
A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31
A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31
A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040419-001AA
A040419-002AA
A040419-003AA

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 22:54:322026-06A040419-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAARS2001-05-31a50c72e98297…
2026-08-01 22:54:322026-06A040419-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAARS2001-05-31a50c72e98297…
2026-08-01 22:54:322026-06A040419-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAARS2001-05-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040419-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A040419-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A040419-003AA1a50c72e98297…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESpecGx LLCeadc80fa-13c3-471a-a22f-6fe7e1ab290f2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEUnit Dose Solutions, Inc.537245e8-5e2a-c3e0-e063-6394a90ac8582026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESt. Mary's Medical Park Pharmacyeac5f350-93e5-4dc2-e053-2a95a90aed602026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions9ca1321e-380a-48d7-8a58-c6501858c1c02026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutionsdff53120-a609-4720-bd69-2391798c7dee2026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions297dc9ff-e34f-434b-b1a4-4c995a5bac8b2026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.55d494b1-c828-4841-8f64-75b92cd54cb62026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.2453d635-989d-4569-96b3-4efaf61cca712026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacka6e9b316-549d-4058-8c08-407e4ce5c2552025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_Rx8d7ca633-4448-3507-e053-2a95a90a12872025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_Rx8d7d6fa4-cc9f-6b4b-e053-2995a90a72862025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.73e2086e-f513-537f-e053-2991aa0a13482025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ndc (package): 68071-4533-5
ndc (product): 68071-4533
ndc11 (package): 68071453305
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEDirect_Rxe78e50c0-36da-528e-e053-2995a90a3d802025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEAphena Pharma Solutions - Tennessee, LLCd53bf9b7-1652-4287-a0c1-e89f6f0cb7f12025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEQuality Care Products, LLC3b455938-7bbc-4626-939b-40b37709befb2024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack3f7737d1-ec78-467e-8903-9cb8eba0ab0b2024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack18315a6f-9e89-46d7-81d3-905b8a51aa792024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LPa8f8bb34-6d61-47a8-b58b-0b67634580522024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.6f2ce909-6356-1c2c-e053-2a91aa0a01352024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
73e2086e-f513-537f-e053-2991aa0a1348Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4533-22025-02-03C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-32025-02-03C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-42025-02-03C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-52025-02-03C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-62025-02-03C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-82025-02-03C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-22025-01-30C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-32025-01-30C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-42025-01-30C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-52025-01-30C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-62025-01-30C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-82025-01-30C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-22021-02-10C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-32021-02-10C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-42021-02-10C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-52021-02-10C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-62021-02-10C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-82021-02-10C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-22021-01-29C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-32021-01-29C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-42021-01-29C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-52021-01-29C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-62021-01-29C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII
68071-4533-82021-01-29C16284748780-1ba0f9c33-37ec-a910-e053-dadaa90a0b85Acetaminophen and Codeine Phosphate Tablets USP CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4533-2ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET205
68071-4533-3ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET305
68071-4533-4ACETAMINOPHEN AND CODEINE PHOSPHATE24 in 1 BOTTLETABLET245
68071-4533-5ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET155
68071-4533-6ACETAMINOPHEN AND CODEINE PHOSPHATE60 in 1 BOTTLETABLET605
68071-4533-8ACETAMINOPHEN AND CODEINE PHOSPHATE84 in 1 BOTTLETABLET845

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4533ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 6 package rows20250206_73e2086e-f513-537f-e053-2991aa0a1348.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN73e2086e-f513-537f-e053-2991aa0a13485
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD73e2086e-f513-537f-e053-2991aa0a13485
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY73e2086e-f513-537f-e053-2991aa0a13485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4533-56807145330515 TABLET in 1 BOTTLE (68071-4533-5) 15 tablet2018-08-200000-00-00NoNoCurrent