HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
60429-590
11-digit product format
604290590
Labeler code
60429
Product ID
60429-590_28f3a26a-dadc-492c-e063-6294a90a817f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA040409
Marketing category
ANDA
Marketing start
2000-10-20
Marketing end
2027-06-30
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
Current FDA listing
Yes

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

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
A040409-001ANEXSIA 5/325ACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAARS2000-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040409-001AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-203f01610625f2…
2019-09-15 20:21 UTC2019-09A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAA2000-10-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040409-001ANEXSIA 5/325325MG;5MGTABLET / ORALAARS2000-10-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040409-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040409-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040409-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040409-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040409-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040409-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040409-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040409-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040409-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040409-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040409-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040409-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040409-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040409-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040409-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040409-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040409-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040409-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040409-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040409-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040409-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040409-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040409-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040409-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040409-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040409-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040409-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040409-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040409-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040409-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040409-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040409-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040409-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040409-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040409-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040409-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040409-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040409-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040409-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040409-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE325 mg/1
ACETAMINOPHEN5 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 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87ed3420-1697-6f42-e053-2995a90a1a5bAvailable 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
60429-590-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET10012
60429-590-05HYDROCODONE BITARTRATE AND ACETAMINOPHEN500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-590-01EA - Each60429-590763cd376-7cb0-427e-8ea6-ae20a64c8bf712019-06-19
60429-590-05EA - Each60429-590bf5b3693-4598-48d6-b6bd-208fd1d92dce12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]12Current NDC, Legacy NDC, 2 package rows20241213_87ed3420-1697-6f42-e053-2995a90a1a5b.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3d3292f0-93b5-1fd0-e063-6294a90a37162026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLC73c1059b-0c7d-42ef-9827-f018858fc4472026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENA-S Medication Solutionsfc61200e-cc40-47c4-8792-c939c9877ae22026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Incfa1b7586-fb26-5e37-e053-6394a90aa92d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rxf0e66441-668a-7ab8-e053-2995a90aba4f2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLC53941807-072e-4783-819d-106ea904eda22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.87ed3420-1697-6f42-e053-2995a90a1a5b2024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409
ndc (product): 60429-590
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP9bad45b7-32ce-47aa-bfdf-8e6a755130562024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040409
application number: ANDA040409

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN87ed3420-1697-6f42-e053-2995a90a1a5b12
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN87ed3420-1697-6f42-e053-2995a90a1a5b12
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN87ed3420-1697-6f42-e053-2995a90a1a5b12
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD87ed3420-1697-6f42-e053-2995a90a1a5b12
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD87ed3420-1697-6f42-e053-2995a90a1a5b12
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD87ed3420-1697-6f42-e053-2995a90a1a5b12
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY87ed3420-1697-6f42-e053-2995a90a1a5b12
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY87ed3420-1697-6f42-e053-2995a90a1a5b12
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY87ed3420-1697-6f42-e053-2995a90a1a5b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-590-0160429059001100 TABLET in 1 BOTTLE (60429-590-01) 100 tablet2019-05-092027-06-30NoNoCurrent
60429-590-0560429059005500 TABLET in 1 BOTTLE (60429-590-05) 500 tablet2019-05-092026-12-31NoNoCurrent