FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
67296-1623
Requested package NDC
67296-1623-4
11-digit product format
672961623
Labeler code
67296
Product ID
67296-1623_b8d0796c-80c5-1386-e053-2a95a90a676f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA209037
Marketing category
ANDA
Marketing start
2018-01-01
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-162367296-1623-4IInactivated by FDA2026-09-14

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2017-06-21
A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2017-06-21
A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2017-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209037-001AA
A209037-002AA
A209037-003AA

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-2184e616aacf4f…
2026-09-14 22:38:342026-08A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-2184e616aacf4f…
2026-09-14 22:38:342026-08A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-2184e616aacf4f…
2026-08-18 06:07:402026-07A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209037-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A209037-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A209037-003AA184e616aacf4f…
2026-08-18 06:07:402026-07A209037-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209037-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209037-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209037-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209037-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209037-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209037-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209037-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209037-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209037-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209037-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209037-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209037-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209037-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209037-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209037-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209037-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209037-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209037-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209037-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209037-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209037-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209037-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209037-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209037-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209037-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209037-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209037-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209037-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209037-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209037-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209037-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209037-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209037-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209037-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209037-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209037-001AA1301d65b070ca…

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, Effective, Related label table
NDCEffectiveRelated label
67296-1623-02026-01-29hydro apap 5/325
67296-1623-12026-01-29hydro apap 5/325
67296-1623-22026-01-29hydro apap 5/325
67296-1623-32026-01-29hydro apap 5/325
67296-1623-42026-01-29hydro apap 5/325
67296-1623-52026-01-29hydro apap 5/325
67296-1623-62026-01-29hydro apap 5/325
67296-1623-72026-01-29hydro apap 5/325
67296-1623-82026-01-29hydro apap 5/325
67296-1623-92026-01-29hydro apap 5/325
67296-1623-02024-07-24hydro apap 5/325
67296-1623-12024-07-24hydro apap 5/325
67296-1623-22024-07-24hydro apap 5/325
67296-1623-32024-07-24hydro apap 5/325
67296-1623-42024-07-24hydro apap 5/325
67296-1623-52024-07-24hydro apap 5/325
67296-1623-62024-07-24hydro apap 5/325
67296-1623-72024-07-24hydro apap 5/325
67296-1623-82024-07-24hydro apap 5/325
67296-1623-92024-07-24hydro apap 5/325
67296-1623-02023-01-30hydro apap 5/325
67296-1623-12023-01-30hydro apap 5/325
67296-1623-22023-01-30hydro apap 5/325
67296-1623-32023-01-30hydro apap 5/325
67296-1623-42023-01-30hydro apap 5/325
67296-1623-52023-01-30hydro apap 5/325
67296-1623-62023-01-30hydro apap 5/325
67296-1623-72023-01-30hydro apap 5/325
67296-1623-82023-01-30hydro apap 5/325
67296-1623-92023-01-30hydro apap 5/325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1623-0Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET4014
67296-1623-1Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET1014
67296-1623-2Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET2014
67296-1623-3Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3014
67296-1623-4Hydrocodone Bitartrate and Acetaminophen4 in 1 BOTTLETABLET414
67296-1623-5Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET1214
67296-1623-6Hydrocodone Bitartrate and Acetaminophen6 in 1 BOTTLETABLET614
67296-1623-7Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET1514
67296-1623-8Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET5014
67296-1623-9Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1623HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]14Legacy NDC, 10 package rows20240725_7b24fc1d-6e2f-47f2-e053-2991aa0a01bb.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENKVK-Tech, Inc.f1063950-b302-4898-81c2-b1626c9c16ef2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209037
application number: ANDA209037
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxcc0e654d-1eaa-7d17-e053-2995a90ab1db2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209037
application number: ANDA209037

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN7b24fc1d-6e2f-47f2-e053-2991aa0a01bb14
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD7b24fc1d-6e2f-47f2-e053-2991aa0a01bb14
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY7b24fc1d-6e2f-47f2-e053-2991aa0a01bb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1623-4672961623044 TABLET in 1 BOTTLE (67296-1623-4) 4 tablet2018-01-010000-00-00NoNoCurrent