Hydrocodone bitartrate and ibuprofen

Product NDC
57664-281
11-digit product format
576640281
Labeler code
57664
Product ID
57664-281_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone bitartrate and ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091633
Marketing category
ANDA
Marketing start
2013-05-28
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; IBUPROFEN
Active strength
3 mg/1; mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-281DDiscontinued by firm2026-10-05
excluded packagepackage57664-28157664-281-08DDiscontinued by firm2026-10-05
excluded packagepackage57664-28157664-281-13DDiscontinued by firm2026-10-05
excluded packagepackage57664-28157664-281-18DDiscontinued by firm2026-10-05
excluded packagepackage57664-28157664-281-83DDiscontinued by firm2026-10-05
excluded packagepackage57664-28157664-281-88DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-281-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-281-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-281-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-281-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-281-83d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-281-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-281-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-281-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-281-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-281-83f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-281-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-281-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-281-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-281-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-281-832ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-281-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-281-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-281-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-281-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-281-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-281-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-281-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-281-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-281-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-281-83cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-281-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-281-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-281-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-281-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-281-83cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-281-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-281-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-281-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-281-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-281-83302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-281-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-281-18ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-281-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-281-88ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-281-83ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-281-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-281-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-281-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-281-880efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-281-830efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-281-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-281-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-281-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-281-88ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-281-83ad56d346431e…cc804d4bbf1e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091633-001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28
A091633-002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28
A091633-003HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28
A091633-004HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-2884e616aacf4f…
2026-09-14 22:38:342026-08A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-2884e616aacf4f…
2026-09-14 22:38:342026-08A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-2884e616aacf4f…
2026-09-14 22:38:342026-08A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-2884e616aacf4f…
2026-08-18 06:07:402026-07A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091633-001HYDROCODONE BITARTRATE AND IBUPROFEN2.5MG;200MGTABLET / ORAL2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091633-002HYDROCODONE BITARTRATE AND IBUPROFEN5MG;200MGTABLET / ORAL2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091633-003HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091633-004HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2013-05-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A091633-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091633-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091633-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091633-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrocodone BitartrateACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
IbuprofenACTIVE INGREDIENTWK2XYI10QMHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
HydrocodoneACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
IbuprofenACTIVE MOIETYWK2XYI10QMHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
polyvinyl alcoholINACTIVE INGREDIENT532B59J990HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPHYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2