Application 040838

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATESOLUTION;ORAL325MG/15ML;7.5MG/15MLNoNo

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

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
A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040838-001AA

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-103f01610625f2…
2019-09-15 20:21 UTC2019-09A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040838-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2013-05-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040838-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040838-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040838-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040838-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040838-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040838-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040838-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040838-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040838-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040838-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040838-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040838-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040838-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040838-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040838-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040838-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040838-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040838-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040838-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040838-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040838-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040838-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040838-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040838-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040838-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040838-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040838-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040838-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040838-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040838-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040838-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040838-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040838-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040838-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040838-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040838-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040838-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040838-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040838-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040838-001AA1cb3db0bc1861…

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENPAI Holdings, LLC dba PAI Pharmac29b97e9-8097-4d87-a420-ccf5aec8274a2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040838
application number: ANDA040838
ndc (product): 0121-1544
ndc (product): 0121-2316
ndc (product): 0121-4772
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENGenus Lifesciences Inc.a9fb9779-76a5-407a-a155-84f198004ae22025-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040838
application number: ANDA040838
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm drug1535f903-8bd0-c09e-e063-6294a90a4d4d2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040838
application number: ANDA040838

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
12634-616Hydrocodone Bitartrate and Acetaminophenhydrocodone bitartrate and acetaminophenApotheca, IncANDACurrent
68788-6352Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76140ORIG 2023-11-03