Hydrocodone Bitatrate and Acetaminophen

Product NDC
55700-216
11-digit product format
557000216
Labeler code
55700
Product ID
55700-216_d9377108-02f5-41a6-ab2d-8cea27219cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitatrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
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
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-216DDiscontinued by firm2026-08-17
excluded packagepackage55700-21655700-216-08DDiscontinued by firm2026-08-17
excluded packagepackage55700-21655700-216-30DDiscontinued by firm2026-08-17
excluded packagepackage55700-21655700-216-60DDiscontinued by firm2026-08-17
excluded packagepackage55700-21655700-216-90DDiscontinued 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 · 60 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 packagepackage55700-216-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-216-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-216-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-216-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-216-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-216-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-216-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-216-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-216-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-216-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-216-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-216-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-216-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-216-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-216-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-216-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-216-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-216-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-216-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-216-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-216-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-216-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-216-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-216-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-216-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-216-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-216-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-216-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-216-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-216-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-216-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-216-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-216-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-216-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-216-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-216-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-216-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-216-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-216-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-216-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-216-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-216-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-216-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-216-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-216-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-216-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-216-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-216-60557ba5c1ecfa…9c80585c8c6e…

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
55700-216-08EA - Each55700-216c9c4c913-2bd8-4b18-b0be-1fe0752276d012015-10-02
55700-216-30EA - Each55700-21659d22f27-37bd-4f1b-97e2-fa0307da409a12015-10-02
55700-216-60EA - Each55700-216baecd475-27cf-41c4-b386-96efbcd4f6e712015-10-02
55700-216-90EA - Each55700-2168087afd4-ef46-42b5-b17c-67f1aa63320012015-10-02