FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
0406-0123
11-digit product format
004060123
Labeler code
0406
Product ID
0406-0123_748bcfb4-7b4c-420c-a9c8-c93fd481f3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA040409
Marketing category
ANDA
Marketing start
2000-10-20
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 5 mg/1; mg/1
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0406-01230406-0123-12DDiscontinued by firm2026-08-11
excluded packagepackage0406-01230406-0123-20DDiscontinued by firm2026-08-11
excluded packagepackage0406-01230406-0123-30DDiscontinued by firm2026-08-11
excluded packagepackage0406-01230406-0123-60DDiscontinued by firm2026-08-11
excluded packagepackage0406-01230406-0123-90DDiscontinued by firm2026-08-11

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
A040409-001ANEXSIA 5/325ACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAARS2000-10-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040409-001AA

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 UTC2026-02A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-203f01610625f2…
2019-09-15 20:21 UTC2019-09A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20cb3db0bc1861…

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 UTC2026-02A040409-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040409-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040409-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040409-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040409-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040409-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040409-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040409-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040409-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040409-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040409-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040409-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040409-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040409-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040409-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040409-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040409-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040409-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040409-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040409-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040409-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040409-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040409-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040409-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040409-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040409-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040409-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040409-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040409-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040409-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040409-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040409-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040409-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040409-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040409-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040409-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040409-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040409-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040409-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040409-001AA1cb3db0bc1861…

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/1
ACETAMINOPHEN5 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856999Internal RxNorm lookup
857002Internal RxNorm lookup
857005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
73c1059b-0c7d-42ef-9827-f018858fc447Available on FDA.report

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
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
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-0123-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET10056
0406-0123-05HYDROCODONE BITARTRATE AND ACETAMINOPHEN500 in 1 BOTTLETABLET50056
0406-0123-10HYDROCODONE BITARTRATE AND ACETAMINOPHEN1000 in 1 BOTTLETABLET100056
0406-0123-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET12056
0406-0123-20HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET2056
0406-0123-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN1 in 1 BLISTER PACKTABLET156
0406-0123-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET3056
0406-0123-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET6056
0406-0123-62HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BLISTER PACKTABLET10056
0406-0123-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET9056

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0123-01EA - Each0406-01232de1a9e8-5f8b-4cbf-88a0-bedefcf3d8bc12014-10-03
0406-0123-05EA - Each0406-0123527c40c3-4cd2-451c-bfab-853306ad3d0b12014-10-03
0406-0123-10EA - Each0406-0123b7cbe20e-b45d-47f8-9b22-06d3048ef7be12016-09-02
0406-0123-12EA - Each0406-01232481c529-02f2-4505-bf89-263a3761a73812017-08-11
0406-0123-23EA - Each0406-01230820193b-2600-4e14-a02c-ea5764edf6f112014-10-03
0406-0123-30EA - Each0406-0123f2fc7d6c-e0ee-4b52-9335-590696f8732212018-08-13
0406-0123-62EA - Each0406-0123e0fc8a4f-14d4-44be-ae13-959f7ea5dd8712014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MALLINCKRODT, INC.]29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0123HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SPECGX LLC]54Current NDC, Legacy NDC, 10 package rows20240627_73c1059b-0c7d-42ef-9827-f018858fc447.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3d3292f0-93b5-1fd0-e063-6294a90a37162026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLC73c1059b-0c7d-42ef-9827-f018858fc4472026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
ndc (product): 0406-0123
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENA-S Medication Solutionsfc61200e-cc40-47c4-8792-c939c9877ae22026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Incfa1b7586-fb26-5e37-e053-6394a90aa92d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rxf0e66441-668a-7ab8-e053-2995a90aba4f2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLC53941807-072e-4783-819d-106ea904eda22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.87ed3420-1697-6f42-e053-2995a90a1a5b2024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP9bad45b7-32ce-47aa-bfdf-8e6a755130562024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN73c1059b-0c7d-42ef-9827-f018858fc44756
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN73c1059b-0c7d-42ef-9827-f018858fc44756
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN73c1059b-0c7d-42ef-9827-f018858fc44756
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD73c1059b-0c7d-42ef-9827-f018858fc44756
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD73c1059b-0c7d-42ef-9827-f018858fc44756
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD73c1059b-0c7d-42ef-9827-f018858fc44756
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY73c1059b-0c7d-42ef-9827-f018858fc44756
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY73c1059b-0c7d-42ef-9827-f018858fc44756
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY73c1059b-0c7d-42ef-9827-f018858fc44756
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNfc61200e-cc40-47c4-8792-c939c9877ae29
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDfc61200e-cc40-47c4-8792-c939c9877ae29
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYfc61200e-cc40-47c4-8792-c939c9877ae29
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNf0e66441-668a-7ab8-e053-2995a90aba4f8
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDf0e66441-668a-7ab8-e053-2995a90aba4f8
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYf0e66441-668a-7ab8-e053-2995a90aba4f8
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN53941807-072e-4783-819d-106ea904eda24
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD53941807-072e-4783-819d-106ea904eda24
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY53941807-072e-4783-819d-106ea904eda24
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNfa1b7586-fb26-5e37-e053-6394a90aa92d2
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDfa1b7586-fb26-5e37-e053-6394a90aa92d2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYfa1b7586-fb26-5e37-e053-6394a90aa92d2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN3d3292f0-93b5-1fd0-e063-6294a90a37161
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN117022f5-4d2e-934e-e063-6394a90a22481
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN0ab05226-0f18-c929-e063-6294a90ad95a1
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN9bad45b7-32ce-47aa-bfdf-8e6a755130561
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNfa1b60b1-4954-1211-e053-6394a90a0a461
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD0ab05226-0f18-c929-e063-6294a90ad95a1
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDfa1b60b1-4954-1211-e053-6394a90a0a461
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD3d3292f0-93b5-1fd0-e063-6294a90a37161
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD9bad45b7-32ce-47aa-bfdf-8e6a755130561
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD117022f5-4d2e-934e-e063-6394a90a22481
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYfa1b60b1-4954-1211-e053-6394a90a0a461
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY3d3292f0-93b5-1fd0-e063-6294a90a37161
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY9bad45b7-32ce-47aa-bfdf-8e6a755130561
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY117022f5-4d2e-934e-e063-6394a90a22481
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY0ab05226-0f18-c929-e063-6294a90ad95a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-0123-0100406012301100 TABLET in 1 BOTTLE (0406-0123-01) 100 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-0500406012305500 TABLET in 1 BOTTLE (0406-0123-05) 500 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-10004060123101000 TABLET in 1 BOTTLE (0406-0123-10) 1000 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-1200406012312120 TABLET in 1 BOTTLE (0406-0123-12) 120 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-200040601232020 TABLET in 1 BOTTLE (0406-0123-20) 20 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-23004060123231 TABLET in 1 BLISTER PACK (0406-0123-23) 1 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-300040601233030 TABLET in 1 BOTTLE (0406-0123-30) 30 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-600040601236060 TABLET in 1 BOTTLE (0406-0123-60) 60 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-6200406012362100 TABLET in 1 BLISTER PACK (0406-0123-62) 100 tablet2000-10-200000-00-00NoNoCurrent
0406-0123-900040601239090 TABLET in 1 BOTTLE (0406-0123-90) 90 tablet2000-10-200000-00-00NoNoCurrent