FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
0121-2316
11-digit product format
001212316
Labeler code
0121
Product ID
0121-2316_1c5f2752-d5b9-4830-bc53-31c816f2bc09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA040838
Marketing category
ANDA
Marketing start
2013-07-29
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0121-23160121-2316-40DDiscontinued by firm2026-08-11

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 1 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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…

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 BITARTRATE325 mg/15mL
ACETAMINOPHEN7.5 mg/15mL

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
856940Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c29b97e9-8097-4d87-a420-ccf5aec8274aAvailable 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
0121-2316-15Hydrocodone Bitartrate and Acetaminophen15 mL in 1 CUP, UNIT-DOSESOLUTION1525
0121-2316-40Hydrocodone Bitartrate and Acetaminophen10 in 1 TRAYSOLUTION1025
0121-2316-40Hydrocodone Bitartrate and Acetaminophen4 in 1 CASESOLUTION425
0121-2316-50Hydrocodone Bitartrate and Acetaminophen10 in 1 TRAYSOLUTION1025
0121-2316-50Hydrocodone Bitartrate and Acetaminophen5 in 1 CASESOLUTION525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-2316-15ML - Milliliter0121-2316b441e1cc-9dda-478c-bf55-9d3f89d9824b12017-09-11
0121-2316-40ML - Milliliter0121-2316b5158895-2163-4540-833f-44d2099a7e2b12017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-2316HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]24Current NDC, Legacy NDC, 5 package rows20250306_c29b97e9-8097-4d87-a420-ccf5aec8274a.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 · 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): 0121-2316
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856940HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral SolutionPSNc29b97e9-8097-4d87-a420-ccf5aec8274a25
856940acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral SolutionSCDc29b97e9-8097-4d87-a420-ccf5aec8274a25
856940acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral SolutionSYc29b97e9-8097-4d87-a420-ccf5aec8274a25
856940acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral SolutionSYc29b97e9-8097-4d87-a420-ccf5aec8274a25
856940acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral SolutionSYc29b97e9-8097-4d87-a420-ccf5aec8274a25
856940APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral SolutionSYc29b97e9-8097-4d87-a420-ccf5aec8274a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-2316-150012123161515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
0121-2316-40001212316404 TRAY in 1 CASE (0121-2316-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-2316-15) 4 tray2013-07-290000-00-00NoNoCurrent
0121-2316-50001212316505 TRAY in 1 CASE (0121-2316-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE5 tray2020-05-210000-00-00NoNoCurrent