Hydrocodone Bitartrate And Acetaminophen

Product NDC
66336-748
11-digit product format
663360748
Labeler code
66336
Product ID
66336-748_877be95b-3967-4f8b-b8d7-686fd27c9b21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate And Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA040155
Marketing category
ANDA
Marketing start
1997-04-14
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66336-748IInactivated by FDA2026-10-05
excluded packagepackage66336-74866336-748-20IInactivated by FDA2026-10-05
excluded packagepackage66336-74866336-748-30IInactivated by FDA2026-10-05
excluded packagepackage66336-74866336-748-60IInactivated by FDA2026-10-05
excluded packagepackage66336-74866336-748-90IInactivated by FDA2026-10-05
excluded packagepackage66336-74866336-748-94IInactivated by FDA2026-10-05

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 3 · 132 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 packagepackage66336-748-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-748-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-748-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-748-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-748-94d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-748-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-748-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-748-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-748-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-748-94f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-748-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-748-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-748-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-748-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-748-942ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-748-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-748-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-748-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-748-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-748-94a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-748-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-748-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-748-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-748-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-748-94cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-748-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-748-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-748-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-748-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-748-94cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-748-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-748-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-748-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-748-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-748-94302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-748-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-748-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-748-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-748-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-748-94ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-748-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-748-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-748-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-748-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-748-940efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-748-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-748-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-748-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-748-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-748-94ad56d346431e…cc804d4bbf1e…

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

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
A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE650MG;7.5MGTABLET / ORAL1997-04-14

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-1484e616aacf4f…
2026-08-18 06:07:402026-07A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-143f01610625f2…
2019-09-15 20:21 UTC2019-09A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040155-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN650MG;7.5MGTABLET / ORAL1997-04-14f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-748-20Hydrocodone Bitartrate And Acetaminophen20 in 1 BOTTLE, PLASTICTABLET201
66336-748-30Hydrocodone Bitartrate And Acetaminophen30 in 1 BOTTLE, PLASTICTABLET301
66336-748-60Hydrocodone Bitartrate And Acetaminophen60 in 1 BOTTLE, PLASTICTABLET601
66336-748-90Hydrocodone Bitartrate And Acetaminophen90 in 1 BOTTLE, PLASTICTABLET901
66336-748-94Hydrocodone Bitartrate And Acetaminophen120 in 1 BOTTLE, PLASTICTABLET1201

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-748HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 5 package rows20111013_fd075b8a-4ee8-45cd-bdef-d75cf3480e06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857083HYDROcodone bitartrate 7.5 MG / acetaminophen 650 MG Oral TabletPSNfd075b8a-4ee8-45cd-bdef-d75cf3480e061
857083acetaminophen 650 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDfd075b8a-4ee8-45cd-bdef-d75cf3480e061
857083APAP 650 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYfd075b8a-4ee8-45cd-bdef-d75cf3480e061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-748-206633607482020 in 1 BOTTLE, PLASTICHistorical
66336-748-306633607483030 in 1 BOTTLE, PLASTICHistorical
66336-748-606633607486060 in 1 BOTTLE, PLASTICHistorical
66336-748-906633607489090 in 1 BOTTLE, PLASTICHistorical
66336-748-9466336074894120 in 1 BOTTLE, PLASTICHistorical