Orphenadrine Citrate

Product NDC
50090-0169
11-digit product format
500900169
Labeler code
50090
Product ID
50090-0169_a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040284
Marketing category
ANDA
Marketing start
1998-06-19
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
2027-12-31
Current FDA listing
Yes

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 packagepackage50090-016950090-0169-2DDiscontinued by firm2026-08-03

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
A040284-001ORPHENADRINE CITRATEORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040284-001AB

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 UTC2026-02A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-193f01610625f2…
2019-09-15 20:21 UTC2019-09A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALABRS1998-06-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040284-001ORPHENADRINE CITRATE100MGTABLET, EXTENDED RELEASE / ORALAB1998-06-19cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040284-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040284-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040284-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040284-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040284-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040284-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040284-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040284-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040284-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040284-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040284-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040284-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040284-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040284-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040284-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040284-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040284-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040284-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040284-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040284-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040284-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040284-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040284-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040284-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040284-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040284-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040284-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040284-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040284-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040284-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040284-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040284-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040284-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040284-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040284-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040284-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040284-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040284-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040284-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040284-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Orphenadrine Citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ORPHENADRINE CITRATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X0A40N8I4SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
994521Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80ef7fb4-7c50-4d25-915e-f9d4a2ccd199Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0169-0Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE2019
50090-0169-1Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE3019
50090-0169-2Orphenadrine Citrate14 in 1 BOTTLETABLET, EXTENDED RELEASE1419
50090-0169-5Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0169-0EA - Each50090-01698d113a9c-ac81-480d-8b7d-2c1cbc2a9a3e12018-08-13
50090-0169-1EA - Each50090-016905646391-f849-481e-941d-bf62a5bb1a8d12018-08-13
50090-0169-2EA - Each50090-016929b136af-8ccb-42cb-9790-ba341f92f4ab12018-08-13
50090-0169-5EA - Each50090-0169a83b1cdd-583f-4fd5-8337-0d90a87e252f12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0169ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 4 package rows20231204_80ef7fb4-7c50-4d25-915e-f9d4a2ccd199.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orphenadrine CitrateORPHENADRINE CITRATESt. Mary's Medical Park Pharmacy59000b66-166e-75d2-e053-2a91aa0af3c02026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ORPHENADRINE CITRATEORPHENADRINE CITRATEREMEDYREPACK INC.7905e80f-b60b-48e8-8e63-a3e50211bfe42026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ORPHENADRINE CITRATEORPHENADRINE CITRATEBryant Ranch Prepack1b4e379e-8051-421f-a0f4-ad9e6fb9476a2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication Solutions80ef7fb4-7c50-4d25-915e-f9d4a2ccd1992026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ndc (product): 50090-0169
ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.87d78229-f022-4b42-a03c-4e6a985c714f2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ORPHENADRINE CITRATEORPHENADRINE CITRATENorthwind Health Company, LLC106be130-b4f8-5ca1-e063-6294a90a15902026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ORPHENADRINE CITRATEORPHENADRINE CITRATELupin Pharmaceuticals, Inc.7b76c8a7-dd0c-481c-8299-26dfd38ce0662025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
Orphenadrine CitrateORPHENADRINE CITRATEPreferred Pharmaceuticals, Inc.8ca9438d-320f-4499-aee7-6b8ca7cccc652025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
Orphenadrine Citrate ERORPHENADRINE CITRATEAdvanced Rx Pharmacy of Tennessee, LLCb5a6846a-ebb3-1fdd-e053-2a95a90a41302024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ORPHENADRINE CITRATEORPHENADRINE CITRATEAdvanced Rx Pharmacy of Tennessee, LLCfc63d413-39bd-409d-e053-6294a90a14632024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
Orphenadrine CitrateORPHENADRINE CITRATELake Erie Medical DBA Quality Care Products LLC233915f1-7d58-4b4c-a2bb-e73179d61d072024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch Prepack8408d24e-3948-548d-bb12-b1edf0c05e122024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
Orphenadrine CitrateORPHENADRINE CITRATENuCare Pharmaceuticals, Inc.3eb1b1cc-ed7a-6f0f-e054-00144ff88e882024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
Orphenadrine CitrateORPHENADRINE CITRATEProficient Rx LPcf620257-7497-44c1-9853-87f96d262fbd2023-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN80ef7fb4-7c50-4d25-915e-f9d4a2ccd19919
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD80ef7fb4-7c50-4d25-915e-f9d4a2ccd19919
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY80ef7fb4-7c50-4d25-915e-f9d4a2ccd19919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0169-05009001690020 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-0) 2016-06-210000-00-00NoNoCurrent
50090-0169-15009001690130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-1) 2014-11-280000-00-00NoNoCurrent
50090-0169-25009001690214 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-2) 2014-11-280000-00-00NoNoCurrent
50090-0169-55009001690560 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-5) 2014-11-280000-00-00NoNoCurrent