Orphenadrine Citrate

Product NDC
50090-3150
11-digit product format
500903150
Labeler code
50090
Product ID
50090-3150_c6e2ac44-d484-4486-8a05-486ef706350d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040368
Marketing category
ANDA
Marketing start
2000-06-23
Marketing end
0000-00-00
Substance
ORPHENADRINE CITRATE
Active strength
100 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3150IInactivated by FDA2026-08-07
excluded packagepackage50090-315050090-3150-0IInactivated by FDA2026-08-07
excluded packagepackage50090-315050090-3150-1IInactivated by FDA2026-08-07
excluded packagepackage50090-315050090-3150-2IInactivated by FDA2026-08-07
excluded packagepackage50090-315050090-3150-5IInactivated by FDA2026-08-07

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 2 · 75 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 packagepackage50090-3150-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3150-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3150-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3150-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3150-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3150-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3150-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3150-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3150-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3150-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3150-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3150-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3150-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3150-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3150-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3150-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3150-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3150-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3150-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3150-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3150-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3150-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3150-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3150-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3150-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3150-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3150-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3150-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3150-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3150-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3150-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3150-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3150-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3150-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3150-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3150-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3150-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3150-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3150-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3150-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3150-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3150-5367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3150-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3150-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3150-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3150-5557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3150-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3150-2557ba5c1ecfa…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
A040368-001ORPHENADRINE CITRATEORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23

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 UTC2026-02A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-06-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-06-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-06-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-06-233f01610625f2…
2019-09-15 20:21 UTC2019-09A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-06-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB2000-06-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040368-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORAL2000-06-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040368-001AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A040368-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040368-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040368-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040368-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040368-001AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3150-0Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE207
50090-3150-1Orphenadrine Citrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE307
50090-3150-2Orphenadrine Citrate14 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE147
50090-3150-5Orphenadrine Citrate60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3150-0EA - Each50090-315039361858-83b1-4c0a-8c49-021f3263b9f412018-12-13
50090-3150-1EA - Each50090-31507006f2ac-bfad-482a-8575-fa0816c9335812019-05-02
50090-3150-5EA - Each50090-3150454820d2-a4bf-4ab1-8a40-522baf10f68c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3150ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 4 package rows20190427_75237fb5-b1bc-479d-97d1-8fad599864b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN75237fb5-b1bc-479d-97d1-8fad599864b87
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD75237fb5-b1bc-479d-97d1-8fad599864b87
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY75237fb5-b1bc-479d-97d1-8fad599864b87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3150-05009031500020 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-3150-0) 2017-10-030000-00-00NoNoCurrent
50090-3150-15009031500130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3150-1) 2014-11-280000-00-00NoNoCurrent
50090-3150-25009031500214 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3150-2) 2014-11-280000-00-00NoNoCurrent
50090-3150-55009031500560 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3150-5) 2014-11-280000-00-00NoNoCurrent