FDA.reportPublic FDA data

Application 040419

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;15MGNoYes
002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoNo
003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;60MGNoNo

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
ndc (product): 0406-0485
ndc (product): 0406-0484
ndc (product): 0406-0483
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
ndc (product): 60760-581
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
ndc (product): 50090-3011
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
ndc (product): 50090-4610
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
ndc (product): 50090-4611
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
ndc (product): 61919-484
ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_Rx8d7d6fa4-cc9f-6b4b-e053-2995a90a72862025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040419
application number: ANDA040419
ndc (product): 61919-484
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
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
ndc (product): 67544-002
ndc (product): 67544-003
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
ndc (product): 49999-060
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
ndc (product): 63629-3031
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
ndc (product): 63187-106
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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 99 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
10544-032ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBlenheim Pharmacal, Inc.ANDACurrent
21695-242ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateRebel Distributors Corp.ANDACurrent
21695-243ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateRebel Distributors Corp.ANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateQuality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-3011ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3011ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3011ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3871ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3871ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4610ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4610ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4611ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4611ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
53217-370ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAidarex Pharmaceuticals LLCANDACurrent
55045-1580ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateDispensing Solutions, Inc.ANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal Health 107, LLCANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
58118-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
60760-581ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateST. MARY'S MEDICAL PARK PHARMACYANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDIRECT RXANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63629-3031ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-3031Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
63629-3031Acetaminophen and Codeine Phosphateacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
67046-886ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatecoupler enterprises inc.ANDACurrent
67046-901ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateContract Pharmacy Services-PAANDACurrent
67296-0065ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedPharm DrugANDACurrent
67296-0065ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedPharm DrugANDACurrent
67296-0065ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedPharm DrugANDACurrent
67544-002ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-002ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-003ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-003ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-2800ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76179ORIG 2023-11-03
29952ORIG2001-05-31