FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
0121-0772
Requested package NDC
0121-0772-04
11-digit product format
001210772
Labeler code
0121
Product ID
0121-0772_e17e391f-c75d-1bdc-e053-2a95a90a9401
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA040838
Marketing category
ANDA
Marketing start
2013-07-29
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0121-07720121-0772-04DDiscontinued 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 · 6 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…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0772-04ML - Milliliter0121-07723925801d-1277-45a1-b78b-bc83d08c3d7612013-10-17
0121-0772-16ML - Milliliter0121-0772e470da89-0a1f-4716-bd48-f2a7c30e51a812013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]2

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
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 SolutionPSN0bf44dc5-fed8-47a2-8606-4966e935775d5
856940acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral SolutionSCD0bf44dc5-fed8-47a2-8606-4966e935775d5
856940acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral SolutionSY0bf44dc5-fed8-47a2-8606-4966e935775d5
856940acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral SolutionSY0bf44dc5-fed8-47a2-8606-4966e935775d5
856940acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral SolutionSY0bf44dc5-fed8-47a2-8606-4966e935775d5
856940APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral SolutionSY0bf44dc5-fed8-47a2-8606-4966e935775d5
856940HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral SolutionPSNf45f5daa-1b76-738f-e053-2995a90a692f2
856940acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral SolutionSCDf45f5daa-1b76-738f-e053-2995a90a692f2
856940acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral SolutionSYf45f5daa-1b76-738f-e053-2995a90a692f2
856940acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral SolutionSYf45f5daa-1b76-738f-e053-2995a90a692f2
856940acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral SolutionSYf45f5daa-1b76-738f-e053-2995a90a692f2
856940APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral SolutionSYf45f5daa-1b76-738f-e053-2995a90a692f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0772-0400121077204118 mL in 1 BOTTLE (0121-0772-04) 118 ml2013-07-290000-00-00NoNoCurrent