FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63187-838
Requested package NDC
63187-838-15
11-digit product format
631870838
Labeler code
63187
Product ID
63187-838_4960f0db-c0f1-4d9c-bca7-8e62861fbfc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040148
Marketing category
ANDA
Marketing start
2014-10-06
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
3 mg/1; mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-83863187-838-15DDiscontinued by firm2026-08-17

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040148-001NORCOACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORAL1997-02-14
A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;10MGTABLET / ORAL1997-02-14
A040148-003NORCOACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORAL2000-09-12
A040148-004NORCOACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;2.5MGTABLET / ORAL2014-07-07
A040148-005NORCOACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORAL2014-07-07

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040148-001NORCO325MG;10MGTABLET / ORAL1997-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040148-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;10MGTABLET / ORAL1997-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040148-003NORCO325MG;7.5MGTABLET / ORAL2000-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040148-004NORCO325MG;2.5MGTABLET / ORAL2014-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040148-005NORCO325MG;5MGTABLET / ORAL2014-07-072680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040148-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040148-003AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040148-004AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040148-005AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040148-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040148-003AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040148-004AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040148-005AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040148-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040148-003AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040148-004AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040148-005AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040148-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040148-003AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040148-004AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040148-005AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040148-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040148-003AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040148-004AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040148-005AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040148-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040148-003AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040148-004AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040148-005AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040148-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040148-003AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040148-004AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040148-005AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040148-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040148-003AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040148-004AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040148-005AA1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-838-60EA - Each63187-83864eb54e5-f62c-4e14-bcab-4d5474b9111612017-06-15
63187-838-90EA - Each63187-838e5faba07-1865-4cbd-ba84-0510f62aca4a12017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-838-156318708381515 TABLET in 1 BOTTLE, PLASTIC (63187-838-15) 15 tablet2017-05-010000-00-00NoNoCurrent