FDA.reportPublic FDA data

HYDROCODONE /APAP

Product NDC
61919-618
Requested package NDC
61919-618-30
11-digit product format
619190618
Labeler code
61919
Product ID
61919-618_ea4ead5d-4576-2d81-e053-2a95a90abe5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE /APAP
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA201013
Marketing category
ANDA
Marketing start
2019-07-17
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
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 packagepackage61919-61861919-618-30IInactivated by FDA2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2012-04-11
A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2012-04-11
A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2012-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A201013-001AA
A201013-002AA
A201013-003AA

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201013-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201013-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201013-001AA18072bd15b7f6…

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#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
61919-618-202cef2736-6b61-d83d-e063-dadaa90ab31fHYDROCODONE/APAP
61919-618-262cef2736-b4c2-d83d-e063-dadaa90ab31fHYDROCODONE/APAP
61919-618-302cef2736-62cc-d83d-e063-dadaa90ab31fHYDROCODONE/APAP
61919-618-602cef2736-6e33-d83d-e063-dadaa90ab31fHYDROCODONE/APAP
61919-618-722cef2736-80b4-d83d-e063-dadaa90ab31fHYDROCODONE/APAP
61919-618-902cef2736-b1f9-d83d-e063-dadaa90ab31fHYDROCODONE/APAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-618-72HYDROCODONE /APAP120 in 1 BOTTLETABLET1203
61919-618-20HYDROCODONE /APAP20 in 1 BOTTLETABLET202
61919-618-26HYDROCODONE /APAP26 in 1 BOTTLETABLET262
61919-618-60HYDROCODONE /APAP60 in 1 BOTTLETABLET602
61919-618-90HYDROCODONE /APAP90 in 1 BOTTLETABLET902
61919-618-30HYDROCODONE /APAP30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-618-20EA - Each61919-6184ad533d7-7f12-4d12-886f-6586e467a0db12019-09-05
61919-618-26EA - Each61919-618a95997a1-e835-4323-8dcb-28d1d945818812019-09-05
61919-618-30EA - Each61919-6187d7f6f44-47d5-4057-8004-ba537db2272612019-04-11
61919-618-60EA - Each61919-61884061ac7-9703-4e5c-bcad-2e0635b1acbe12019-08-06
61919-618-72EA - Each61919-61800a87645-3f52-4708-8478-c9defb9e2a7512019-07-02
61919-618-90EA - Each61919-618d2c8ca68-66d0-410f-9e1d-310d3976011612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-618HYDROCODONE /APAP TABLET [DIRECT_RX]3Legacy NDC, 1 package rows20221007_8a9875f5-2889-5149-e053-2995a90a46c0.zip
61919-618HYDROCODONE /APAP TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_8e4795c8-97d0-6a72-e053-2a95a90a196a.zip
61919-618HYDROCODONE /APAP TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_8de1cc02-1643-4a3b-e053-2a95a90a2fb1.zip
61919-618HYDROCODONE /APAP TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_8de12c9f-eb17-aa26-e053-2a95a90a1b9c.zip
61919-618HYDROCODONE /APAP TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20221007_8e48b57b-74fc-10f6-e053-2995a90a04ef.zip
61919-618HYDROCODONE /APAP TABLET [DIRECTRX]1Legacy NDC, 1 package rows20190411_86325900-d617-f02b-e053-2991aa0a8e99.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddfe71cc-27bf-4807-b62f-e6cf982e2dfd2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack88c031ee-3d3d-4e8a-b69b-d18db612a9f32026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC60f43308-1deb-4f05-8f17-aa49ebdcf4982025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack59a92d79-5b2d-4c10-b0ac-ea766a0ff08b2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8b132cf3-c138-59ae-e053-2995a90a98a22024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8c2a7a68-5a84-c909-e053-2995a90ad5b62024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8592e901-9353-6fb6-e053-2a91aa0ad33b2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.86be8920-2f35-fbc3-e053-2991aa0a00152024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP82b24978-8b15-43a9-b5b0-3313ed2a73c22023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPe6711f26-a01d-43e8-882a-d58561e4b67f2022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8a9875f5-2889-5149-e053-2995a90a46c03
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8a9875f5-2889-5149-e053-2995a90a46c03
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8a9875f5-2889-5149-e053-2995a90a46c03
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8de1cc02-1643-4a3b-e053-2a95a90a2fb12
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e48b57b-74fc-10f6-e053-2995a90a04ef2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e4795c8-97d0-6a72-e053-2a95a90a196a2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8de12c9f-eb17-aa26-e053-2a95a90a1b9c2
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8de12c9f-eb17-aa26-e053-2a95a90a1b9c2
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8de1cc02-1643-4a3b-e053-2a95a90a2fb12
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e4795c8-97d0-6a72-e053-2a95a90a196a2
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e48b57b-74fc-10f6-e053-2995a90a04ef2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8de12c9f-eb17-aa26-e053-2a95a90a1b9c2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8de1cc02-1643-4a3b-e053-2a95a90a2fb12
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e4795c8-97d0-6a72-e053-2a95a90a196a2
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e48b57b-74fc-10f6-e053-2995a90a04ef2
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN86325900-d617-f02b-e053-2991aa0a8e991
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD86325900-d617-f02b-e053-2991aa0a8e991
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY86325900-d617-f02b-e053-2991aa0a8e991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-618-306191906183030 TABLET in 1 BOTTLE (61919-618-30) 30 tablet2019-04-100000-00-00NoNoCurrent