FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63304-497
11-digit product format
633040497
Labeler code
63304
Product ID
63304-497_4f875c7a-4454-45a2-bf55-fcc2932c51db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040826
Marketing category
ANDA
Marketing start
2018-07-31
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORAL2007-08-16

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 22:38:342026-08A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-1684e616aacf4f…
2026-08-18 06:07:402026-07A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-163f01610625f2…
2019-09-15 20:21 UTC2019-09A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040826-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2007-08-16f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
HYDROCODONE BITARTRATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
NO70W886KKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856999Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e153073-ca78-481e-9e9c-0365ee3f3d59Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-497-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET10012
63304-497-03Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET1012
63304-497-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50012
63304-497-10Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLETABLET100012
63304-497-11Hydrocodone Bitartrate and Acetaminophen1 in 1 BLISTER PACKTABLET112
63304-497-69Hydrocodone Bitartrate and Acetaminophen10 in 1 CARTONTABLET1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-497-01EA - Each63304-4971c02525c-8912-438d-9273-287e9225eeda12013-07-02
63304-497-05EA - Each63304-497da75a38e-36bd-45f0-8532-ac86260e22e712013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RANBAXY PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-497HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 6 package rows20180731_6e153073-ca78-481e-9e9c-0365ee3f3d59.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.6e153073-ca78-481e-9e9c-0365ee3f3d592018-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040826
application number: ANDA040826
ndc (product): 63304-497

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN6e153073-ca78-481e-9e9c-0365ee3f3d5912
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD6e153073-ca78-481e-9e9c-0365ee3f3d5912
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY6e153073-ca78-481e-9e9c-0365ee3f3d5912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-497-0163304049701100 TABLET in 1 BOTTLE (63304-497-01) 100 tablet2018-07-310000-00-00NoNoCurrent
63304-497-036330404970310 TABLET in 1 BOTTLE (63304-497-03) 10 tablet2018-07-310000-00-00NoNoCurrent
63304-497-0563304049705500 TABLET in 1 BOTTLE (63304-497-05) 500 tablet2018-07-310000-00-00NoNoCurrent
63304-497-10633040497101000 TABLET in 1 BOTTLE (63304-497-10) 1000 tablet2018-07-310000-00-00NoNoCurrent
63304-497-11633040497111 in 1 BLISTER PACKHistorical
63304-497-696330404976910 BLISTER PACK in 1 CARTON (63304-497-69) / 1 TABLET in 1 BLISTER PACK (63304-497-11) 10 blister pack2018-07-310000-00-00NoNoCurrent