FDA.reportPublic FDA data

Application 040119

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATESOLUTION;ORAL120MG/5ML;12MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-2684e616aacf4f…
2026-08-18 06:07:402026-07A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-263f01610625f2…
2019-09-15 20:21 UTC2019-09A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORAL1996-04-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040119-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALAA1996-04-26f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040119-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040119-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040119-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040119-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040119-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040119-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040119-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040119-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040119-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040119-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040119-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040119-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040119-001AA1ea99ee380514…
2024-02-18 07:12 UTC2024-02A040119-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040119-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040119-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040119-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040119-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040119-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040119-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040119-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040119-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040119-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040119-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040119-001AA1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack18315a6f-9e89-46d7-81d3-905b8a51aa792024-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack30da1bea-2dbc-4086-a5cf-8ed471bb65932024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack9f2127d9-d60b-42d3-9b6c-798e63dd68d12024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.1e01f923-38c1-9b59-e063-6394a90a22f12024-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LPa8f8bb34-6d61-47a8-b58b-0b67634580522024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.8f12016d-904f-00b4-e053-2a95a90ad02a2024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.80c9a58d-98ae-5497-e053-2991aa0a61fb2024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.7d69403e-90d0-7a80-e053-2a91aa0a55522024-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.6f2ce909-6356-1c2c-e053-2a91aa0a01352024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEStrides Pharma Science Limitedc459ed02-afd6-4533-82b6-bfb2c7ab0e722024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEClinical Solutions Wholesale, LLC5603ed2f-0b6c-46fd-8c76-c4e4d188a3432024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackebdbc975-4e0e-4b83-8cf4-f29da829113a2024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEClinical Solutions Wholesale, LLC331d92ac-7287-47c7-b573-b5e6cd58c9812024-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP75b50751-5237-4e3e-b7ee-1605c0602f3b2022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-975Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateApotheca Inc.ANDACurrent
17856-0079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAtlantic Biologicals CorpsANDACurrent
17856-0079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAtlantic Biologicals CorpsANDACurrent
17856-0079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateATLANTIC BIOLOGICALS COPR.ANDACurrent
50383-079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-079Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-337Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-337Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-337Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-337Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-337Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-338Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-338Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-338Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-338Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-338Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-339Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-339Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-339Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-339Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-339Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-340Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-340Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-340Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-340Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAkornANDACurrent
50383-340Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
53217-213Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAidarex Pharmaceuticals LLCANDACurrent
67296-0651Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRedPharm Drug Inc.ANDACurrent
68788-0076Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76069ORIG 2023-11-02