FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
64850-631
11-digit product format
648500631
Labeler code
64850
Product ID
64850-631_91acad07-a9ce-450e-b9f6-4401b89bd32c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Elite Laboratories, Inc.
Application
ANDA209924
Marketing category
ANDA
Marketing start
2018-11-16
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
2026-12-31
Current FDA listing
Yes

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.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage64850-631-60
excluded packagepackage64850-631-30
excluded packagepackage64850-631-90

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;2.5MGTABLET / ORALAA2018-11-16
A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2018-11-16
A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2018-11-16
A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2018-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209924-001AA
A209924-002AA
A209924-003AA
A209924-004AA

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2018-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2018-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2018-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2018-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-16d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209924-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209924-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209924-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209924-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209924-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209924-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209924-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209924-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209924-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209924-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209924-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209924-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209924-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209924-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209924-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209924-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209924-004AA12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209924-004AA1d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209924-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209924-002AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209924-003AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209924-004AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE5 mg/1
ACETAMINOPHEN325 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856999Internal RxNorm lookup
857002Internal RxNorm lookup
857005Internal RxNorm lookup
857391Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89b8145f-5310-4b58-a65d-586dc90d642dAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64850-631-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLE, PLASTICTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64850-631-01EA - Each64850-6311684064c-0ef3-458d-b135-308ec48105b612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64850-631HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ELITE LABORATORIES, INC.]8Current NDC, Legacy NDC, 1 package rows20240831_89b8145f-5310-4b58-a65d-586dc90d642d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENElite Laboratories, Inc.89b8145f-5310-4b58-a65d-586dc90d642d2025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209924
application number: ANDA209924
ndc (product): 64850-631

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
857391HYDROcodone bitartrate 2.5 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
857391acetaminophen 325 MG / hydrocodone bitartrate 2.5 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10
857391APAP 325 MG / Hydrocodone Bitartrate 2.5 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64850-631-0164850063101100 TABLET in 1 BOTTLE, PLASTIC (64850-631-01) 100 tablet2018-11-16NoNoCurrent