ORPHENADRINE CITRATE

Product NDC
61919-507
Requested package NDC
61919-507-30
11-digit product format
619190507
Labeler code
61919
Product ID
61919-507_9cab5838-6e00-a78d-e053-2995a90a095e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040284
Marketing category
ANDA
Marketing start
2018-03-26
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
2021-12-31
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 packagepackage61919-50761919-507-30IInactivated by FDA2026-08-11

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 · 15 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…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-507-302023-01-30C16284748780-1f386c64a-1b5d-0266-e053-dadaa90a7c1aORPHENADRINE CITRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-507-30ORPHENADRINE CITRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-507-30EA - Each61919-5071867435a-03ef-4024-a9e2-5d7fc6114ef412018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-507ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20200122_68520968-23bb-6ae9-e053-2991aa0a773d.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
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 TabletPSN68520968-23bb-6ae9-e053-2991aa0a773d2
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD68520968-23bb-6ae9-e053-2991aa0a773d2
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY68520968-23bb-6ae9-e053-2991aa0a773d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-507-306191905073030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-507-30) 2018-03-260000-00-00NoNoCurrent