HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
45865-407
11-digit product format
458650407
Labeler code
45865
Product ID
45865-407_feab4bc9-ea2d-41fe-bf5e-99c2897df8b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA089160
Marketing category
ANDA
Marketing start
2010-04-22
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-407IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-06IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-15IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-20IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-30IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-49IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-51IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-57IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-60IInactivated by FDA2026-08-17
excluded packagepackage45865-40745865-407-90IInactivated by FDA2026-08-17

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 4 · 220 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-57d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-49d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-407-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-57f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-49f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-407-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-572ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-512ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-492ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-407-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-57a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-49a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-407-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-57cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-51cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-49cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-407-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-57cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-51cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-49cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-407-60cdf11ea48f46…ba0047e9e063…

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
A089160-001ANEXSIAACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;5MGTABLET / ORAL1987-04-23

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 06:07:402026-07A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-233f01610625f2…
2019-09-15 20:21 UTC2019-09A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089160-001ANEXSIA500MG;5MGTABLET / ORAL1987-04-23e64feba35796…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-407-06HYDROCODONE BITARTRATE AND ACETAMINOPHEN6 in 1 BOTTLETABLET61
45865-407-15HYDROCODONE BITARTRATE AND ACETAMINOPHEN15 in 1 BOTTLETABLET151
45865-407-20HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET201
45865-407-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET301
45865-407-49HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET1001
45865-407-51HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1201
45865-407-57HYDROCODONE BITARTRATE AND ACETAMINOPHEN180 in 1 BOTTLETABLET1801
45865-407-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET601
45865-407-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET901

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-407HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 9 package rows20120725_77e4446e-78a0-4596-9679-15938eb0f892.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSN77e4446e-78a0-4596-9679-15938eb0f8921
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCD77e4446e-78a0-4596-9679-15938eb0f8921
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSY77e4446e-78a0-4596-9679-15938eb0f8921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-407-06458650407066 in 1 BOTTLEHistorical
45865-407-154586504071515 in 1 BOTTLEHistorical
45865-407-204586504072020 in 1 BOTTLEHistorical
45865-407-304586504073030 in 1 BOTTLEHistorical
45865-407-4945865040749100 in 1 BOTTLEHistorical
45865-407-5145865040751120 in 1 BOTTLEHistorical
45865-407-5745865040757180 in 1 BOTTLEHistorical
45865-407-604586504076060 in 1 BOTTLEHistorical
45865-407-904586504079090 in 1 BOTTLEHistorical