FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
72189-343
Requested package NDC
72189-343-72
11-digit product format
721890343
Labeler code
72189
Product ID
72189-343_2eaccf77-5ca1-97e7-e063-6394a90a7c39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA211487
Marketing category
ANDA
Marketing start
2022-03-30
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 · 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
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-34372189-343-72UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-34372189-343-72UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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

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
A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;2.5MGTABLET / ORALAARS2018-11-07
A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2018-11-07
A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2018-11-07
A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2018-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211487-001AA
A211487-002AA
A211487-003AA
A211487-004AA

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-0784e616aacf4f…
2026-09-14 22:38:342026-08A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-0784e616aacf4f…
2026-09-14 22:38:342026-08A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-0784e616aacf4f…
2026-09-14 22:38:342026-08A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-0784e616aacf4f…
2026-08-18 06:07:402026-07A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAARS2018-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211487-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALRS2018-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211487-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211487-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211487-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211487-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A211487-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A211487-003AA184e616aacf4f…
2026-09-14 22:38:342026-08A211487-004AA184e616aacf4f…
2026-08-18 06:07:402026-07A211487-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A211487-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A211487-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A211487-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211487-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211487-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211487-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211487-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211487-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211487-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211487-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211487-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211487-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211487-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211487-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211487-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211487-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211487-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211487-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211487-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211487-001AA1d8e5a09893c0…

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
NO70W886KKInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db73b8ed-9747-6a49-e053-2a95a90a93a1Available 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
72189-343-08HYDROCODONE BITARTRATE AND ACETAMINOPHEN8 in 1 BOTTLETABLET811
72189-343-20HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET2011
72189-343-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET3011
72189-343-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET6011
72189-343-72HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET12011
72189-343-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-343-08EA - Each72189-343453141a8-9ac0-49c3-9a2a-722bd815f4d412022-10-06
72189-343-20EA - Each72189-34337234f02-cbf3-4364-ab9a-cd784606d12e12025-03-04
72189-343-30EA - Each72189-343a70ae793-99d6-4891-be62-d86b957703df12022-05-04
72189-343-60EA - Each72189-343af64ce39-7d7d-4b72-a578-ab1da96205c812022-07-06
72189-343-72EA - Each72189-343b1fc6fa6-c2ad-4b29-99ba-90c893153d2a12022-06-06
72189-343-90EA - Each72189-343285a9d69-cfbd-4aae-9503-e99a2b3ce7f112022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DIRECT RX]11Current NDC, Legacy NDC, 6 package rows20250224_db73b8ed-9747-6a49-e053-2a95a90a93a1.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc4dc75b4-8016-4875-a859-6346c48cc0e72025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack39b8382a-e96d-462d-895f-27cbb9a305ec2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackac88fa99-625b-4854-a406-9e21a6b9c1c82025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackee4b164d-7ee2-4c19-b1a3-cb60c66767862025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack94ba2279-440e-4eaf-ad19-04d90a5c4c102025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack177c4cd8-80dd-4ed7-9e12-dcec70e0278e2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack96a84a12-da15-410a-9c70-af125f2fcacc2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5d5fa7bb-6416-48dc-95a0-43ffd84cb5952025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack72244b9c-eac4-41c2-8ba6-7302eafba90a2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.4d5bfd3a-3793-4d24-aedd-c04fa34ea7362025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.ed6af366-753c-4f3b-a6a2-c9a183c500352025-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect Rxdb73b8ed-9747-6a49-e053-2a95a90a93a12025-02-21Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
ndc (package): 72189-343-72
ndc (product): 72189-343
ndc11 (package): 72189034372
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxdd934235-3b2a-51ca-e053-2995a90a00162025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone APAPHYDROCODONE APAPDirect_Rxdeaa53c1-81ed-7497-e053-2995a90a07cc2025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.b9f61b9c-d3f9-47e3-94a3-b5228f96f9272023-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPc6210466-5feb-45d9-b637-b3f482bc3c2b2022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.73dea6de-20cb-4cef-b987-3ab2c64e5edb2019-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211487
application number: ANDA211487

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNdb73b8ed-9747-6a49-e053-2a95a90a93a111
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDdb73b8ed-9747-6a49-e053-2a95a90a93a111
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYdb73b8ed-9747-6a49-e053-2a95a90a93a111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-343-7272189034372120 TABLET in 1 BOTTLE (72189-343-72) 120 tablet2022-03-300000-00-00NoNoCurrent