FDA.reportPublic FDA data

HYDROCODONE BITARTRATE and ACETAMINOPHEN

Product NDC
69101-600
11-digit product format
691010600
Labeler code
69101
Product ID
69101-600_96b0c532-b1a7-f6c5-e053-2a95a90a4af2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Dosage form
SOLUTION
Route
ORAL
Labeler
Burke Therapeutics, LLC
Application
ANDA040834
Marketing category
ANDA
Marketing start
2015-03-18
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69101-600DDiscontinued by firm2026-08-11
excluded packagepackage69101-60069101-600-08DDiscontinued by firm2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69101-600-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69101-600-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69101-600-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69101-600-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69101-600-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69101-600-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69101-600-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69101-600-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69101-600-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69101-600-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69101-600-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69101-600-08557ba5c1ecfa…9c80585c8c6e…

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
A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18

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 UTC2026-02A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-183f01610625f2…
2019-09-15 20:21 UTC2019-09A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040834-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;10MG/15MLSOLUTION / ORALRS2008-04-18cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69101-600-08ML - Milliliter69101-60090f44877-9366-4c86-9a68-a6a4294c7f2212018-12-13
69101-600-15ML - Milliliter69101-60028772d7a-dc69-4651-b422-63c91f761b8912018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69101-600-08691010600088 CUP, UNIT-DOSE in 1 TRAY (69101-600-08) > 15 mL in 1 CUP, UNIT-DOSE (69101-600-15) 2018-11-080000-00-00NoNoCurrent