Lorzone

Product NDC
55700-517
11-digit product format
557000517
Labeler code
55700
Product ID
55700-517_8a39c07e-59e5-43cc-96a3-9d6ae39b04d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA040861
Marketing category
ANDA
Marketing start
2011-10-01
Marketing end
0000-00-00
Substance
CHLORZOXAZONE
Active strength
375 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
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 productproduct55700-517DDiscontinued by firm2026-08-17
excluded packagepackage55700-51755700-517-30DDiscontinued 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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-517-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-517-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-517-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-517-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-517-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-517-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-517-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-517-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-517-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-517-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-517-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-517-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-517-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-517-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-517-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55700-517-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55700-517-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55700-517-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55700-517-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040861-001CHLORZOXAZONECHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01
A040861-002CHLORZOXAZONECHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040861-001AB
A040861-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040861-001CHLORZOXAZONE375MGTABLET / ORAL2010-06-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040861-002CHLORZOXAZONE750MGTABLET / ORALRS2010-06-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040861-001CHLORZOXAZONE375MGTABLET / ORALABRS2010-06-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040861-002CHLORZOXAZONE750MGTABLET / ORALABRS2010-06-01bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040861-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040861-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040861-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040861-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040861-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040861-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040861-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040861-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040861-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040861-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040861-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040861-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040861-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040861-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040861-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040861-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040861-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040861-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040861-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040861-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040861-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040861-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040861-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040861-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040861-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A040861-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040861-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040861-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040861-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-517-302025-01-09C16284748780-1ba0f9c33-554f-a910-e053-dadaa90a0b85cd269b7c-3bcf-4caf-8f37-3724eea8256d
55700-517-302021-01-29C16284748780-1ba0f9c33-554f-a910-e053-dadaa90a0b85cd269b7c-3bcf-4caf-8f37-3724eea8256d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-517-30EA - Each55700-51730dc592f-fad0-4a8e-bdd8-69dc83c375ca12017-05-04