Hydrocodone Bitartrate and Aspirin

Product NDC
79739-7182
11-digit product format
797397182
Labeler code
79739
Product ID
79739-7182_1bdb6c28-6b01-4e91-863f-bb325d3ee424
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
LGM Pharma Solutions, LLC
Application
ANDA205479
Marketing category
ANDA
Marketing start
2021-05-28
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ASPIRIN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct79739-7182IInactivated by FDA2026-09-09
excluded packagepackage79739-718279739-7182-1IInactivated by FDA2026-09-09

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct79739-7182IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage79739-718279739-7182-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A205479-001HYDROCODONE BITARTRATE AND ASPIRINASPIRIN; HYDROCODONE BITARTRATE500MG;5MGTABLET / ORALRS2021-05-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORAL2021-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORAL2021-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORAL2021-05-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORAL2021-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORAL2021-05-28782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORAL2021-05-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205479-001HYDROCODONE BITARTRATE AND ASPIRIN500MG;5MGTABLET / ORALRS2021-05-28a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79739-7182-12024-03-25C16284748780-11030e365-2bbb-111a-e063-dadaa90a10e2Hydrocodone Bitartrate with Aspirin
79739-7182-12024-01-30C16284748780-11030e365-2bbb-111a-e063-dadaa90a10e2Hydrocodone Bitartrate with Aspirin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79739-7182-1Hydrocodone Bitartrate and Aspirin100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79739-7182HYDROCODONE BITARTRATE AND ASPIRIN TABLET [LGM PHARMA SOLUTIONS, LLC]2Legacy NDC, 1 package rows20240327_1bdb6c28-6b01-4e91-863f-bb325d3ee424.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857121HYDROcodone bitartrate 5 MG / aspirin 500 MG Oral TabletPSN1bdb6c28-6b01-4e91-863f-bb325d3ee4242
857121aspirin 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCD1bdb6c28-6b01-4e91-863f-bb325d3ee4242
857121ASA 500 MG / Hydrocodone Bitartrate 5 MG Oral TabletSY1bdb6c28-6b01-4e91-863f-bb325d3ee4242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79739-7182-179739718201100 TABLET in 1 BOTTLE (79739-7182-1) 100 tablet2021-05-280000-00-00NoNoCurrent