FDA.reportPublic FDA data

IBUDONE

Product NDC
50991-579
11-digit product format
509910579
Labeler code
50991
Product ID
50991-579_7fafdef6-38b6-823a-e053-2991aa0a7fb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Poly Pharmaceuticals
Application
ANDA077723
Marketing category
ANDA
Marketing start
2006-11-06
Marketing end
2019-09-30
Substance
HYDROCODONE BITARTRATE; IBUPROFEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50991-579DDiscontinued by firm2026-08-03
excluded packagepackage50991-57950991-579-01DDiscontinued by firm2026-08-03

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
A077723-001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-06
A077723-002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06
A077723-003HYDROCODONEHYDROCODONE BITARTRATE; IBUPROFEN5MG;200MGTABLET / ORAL2006-11-06

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077723-003HYDROCODONE5MG;200MGTABLET / ORAL2006-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077723-003HYDROCODONE5MG;200MGTABLET / ORAL2006-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077723-003HYDROCODONE5MG;200MGTABLET / ORAL2006-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077723-003HYDROCODONE5MG;200MGTABLET / ORAL2006-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077723-003HYDROCODONE5MG;200MGTABLET / ORAL2006-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077723-003HYDROCODONE5MG;200MGTABLET / ORAL2006-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077723-003HYDROCODONE5MG;200MGTABLET / ORALAB2006-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077723-003HYDROCODONE5MG;200MGTABLET / ORALAB2006-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077723-003HYDROCODONE5MG;200MGTABLET / ORALAB2006-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077723-003HYDROCODONE5MG;200MGTABLET / ORALAB2006-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077723-003HYDROCODONE5MG;200MGTABLET / ORALAB2006-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077723-003HYDROCODONE5MG;200MGTABLET / ORALAB2006-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077723-003HYDROCODONE5MG;200MGTABLET / ORALAB2006-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2006-11-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077723-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077723-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077723-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077723-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077723-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077723-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077723-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077723-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077723-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077723-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077723-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077723-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077723-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077723-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077723-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077723-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077723-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077723-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077723-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077723-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077723-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077723-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077723-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077723-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077723-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077723-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077723-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077723-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077723-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077723-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077723-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077723-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077723-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077723-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077723-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077723-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077723-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077723-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077723-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077723-002AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-579-01EA - Each50991-579a65634b3-1f29-4959-8966-70b2cde7f17f12012-07-24