FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
60687-417
11-digit product format
606870417
Labeler code
60687
Product ID
60687-417_45262987-a079-3a9e-e063-6294a90aa223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA211023
Marketing category
ANDA
Marketing start
2019-06-19
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 mg/15mL; mg/15mL
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

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
A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2019-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211023-001AA

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 UTC2026-02A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2019-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2019-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2019-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2019-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-083f01610625f2…
2019-09-15 20:21 UTC2019-09A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211023-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAA2019-03-08cb3db0bc1861…

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 UTC2026-02A211023-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211023-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211023-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211023-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211023-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211023-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211023-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211023-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211023-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211023-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211023-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211023-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211023-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211023-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211023-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211023-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211023-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211023-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211023-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211023-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211023-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A211023-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211023-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211023-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211023-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A211023-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211023-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211023-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211023-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211023-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211023-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211023-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211023-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211023-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211023-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211023-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211023-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211023-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211023-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211023-001AA1cb3db0bc1861…

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 BITARTRATE325 mg/15mL
ACETAMINOPHEN7.5 mg/15mL

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
856940Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f55d0cc9-996e-49c2-b8c1-acaceac99afeAvailable 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
60687-417-44Hydrocodone Bitartrate and Acetaminophen15 mL in 1 CUP, UNIT-DOSESOLUTION156
60687-417-50Hydrocodone Bitartrate and Acetaminophen10 in 1 TRAYSOLUTION106
60687-417-71Hydrocodone Bitartrate and Acetaminophen5 in 1 CASESOLUTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-417-44ML - Milliliter60687-417f8fa6112-4426-47f4-944f-7b57b470338212019-07-02
60687-417-71ML - Milliliter60687-417ed7fa0ef-6dfb-420f-a0b7-125f02ad9c7c12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-417HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 3 package rows20240524_f55d0cc9-996e-49c2-b8c1-acaceac99afe.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Incadb37532-aa19-48a2-95a1-8c92a6ce86512026-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211023
application number: ANDA211023
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm Drug37451478-b961-873b-e063-6394a90a7b4e2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211023
application number: ANDA211023
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmerican Health Packagingf55d0cc9-996e-49c2-b8c1-acaceac99afe2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211023
application number: ANDA211023
ndc (product): 60687-417

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856940HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral SolutionPSNf55d0cc9-996e-49c2-b8c1-acaceac99afe6
856940acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral SolutionSCDf55d0cc9-996e-49c2-b8c1-acaceac99afe6
856940acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral SolutionSYf55d0cc9-996e-49c2-b8c1-acaceac99afe6
856940acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral SolutionSYf55d0cc9-996e-49c2-b8c1-acaceac99afe6
856940acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral SolutionSYf55d0cc9-996e-49c2-b8c1-acaceac99afe6
856940APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral SolutionSYf55d0cc9-996e-49c2-b8c1-acaceac99afe6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-417-446068704174415 mL in 1 CUP, UNIT-DOSE15 mlHistorical
60687-417-506068704175010 in 1 TRAYHistorical
60687-417-71606870417715 TRAY in 1 CASE (60687-417-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-417-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-417-44) 5 tray2019-06-190000-00-00NoNoCurrent