FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
0054-0843
Requested package NDC
0054-0843-63
11-digit product format
000540843
Labeler code
0054
Product ID
0054-0843_250056d2-c06c-76f1-e063-6394a90aec19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
LIQUID
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040881
Marketing category
ANDA
Marketing start
2025-06-02
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
300; 10 mg/15mL; mg/15mL
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 42.

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
A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALAARS2010-02-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALAARS2010-02-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALAARS2010-02-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A040881-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040881-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A040881-001AA1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE300 mg/15mL
ACETAMINOPHEN10 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044427Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
995a6cc7-8b72-4d35-b3b4-8c5752438fb7Available 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
0054-0843-63HYDROCODONE BITARTRATE AND ACETAMINOPHEN473 mL in 1 BOTTLELIQUID4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0843-63ML - Milliliter0054-08431beb9f8d-78f9-4e69-8628-cbd987aadc7a12025-07-08

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 ACETAMINOPHENHikma Pharmaceuticals USA Inc.995a6cc7-8b72-4d35-b3b4-8c5752438fb72026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040881
application number: ANDA040881
ndc (package): 0054-0843-63
ndc (product): 0054-0843
ndc11 (package): 00054084363

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044427HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral SolutionPSN995a6cc7-8b72-4d35-b3b4-8c5752438fb72
1044427acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral SolutionSCD995a6cc7-8b72-4d35-b3b4-8c5752438fb72
1044427APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral SolutionSY995a6cc7-8b72-4d35-b3b4-8c5752438fb72
1044427APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral SolutionSY995a6cc7-8b72-4d35-b3b4-8c5752438fb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0054-0843-6300054084363473 mL in 1 BOTTLE (0054-0843-63) 473 ml2025-06-16NoNoCurrent