Application 040284

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORPHENADRINE CITRATEORPHENADRINE CITRATETABLET, EXTENDED RELEASE;ORAL100MGNoNo

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…

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
ndc (product): 60760-810
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
ndc (product): 43063-407
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
ndc (product): 43386-480
Orphenadrine CitrateORPHENADRINE CITRATEPreferred Pharmaceuticals, Inc.8ca9438d-320f-4499-aee7-6b8ca7cccc652025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ndc (product): 68788-9138
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
ndc (product): 80425-0117
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
ndc (product): 49999-046
Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch Prepack8408d24e-3948-548d-bb12-b1edf0c05e122024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ndc (product): 63629-1564
Orphenadrine CitrateORPHENADRINE CITRATENuCare Pharmaceuticals, Inc.3eb1b1cc-ed7a-6f0f-e054-00144ff88e882024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ndc (product): 66267-158
Orphenadrine CitrateORPHENADRINE CITRATEProficient Rx LPcf620257-7497-44c1-9853-87f96d262fbd2023-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040284
application number: ANDA040284
ndc (product): 63187-122

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-283Orphenadrine CitrateOrphenadrine CitrateBlenheim Pharmacal, Inc.ANDACurrent
21695-099Orphenadrine CitrateOrphenadrine CitrateRebel Distributors CorpANDACurrent
33261-088Orphenadrine CitrateOrphenadrine CitrateAidarex Pharmaceuticals LLCANDACurrent
33358-274Orphenadrine CitrateOrphenadrine CitrateRxChange Co.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-407ORPHENADRINE CITRATEORPHENADRINE CITRATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43386-480ORPHENADRINE CITRATEORPHENADRINE CITRATELupin Pharmaceuticals, Inc.ANDACurrent
49999-046Orphenadrine CitrateOrphenadrine CitrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-046Orphenadrine CitrateOrphenadrine CitrateLake Erie Medical DBA QuaANDACurrent
49999-046Orphenadrine CitrateOrphenadrine CitrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0169Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
50090-0169Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
50090-0169Orphenadrine CitrateORPHENADRINE CITRATEA-S Medication SolutionsANDACurrent
50436-7601Orphenadrine CitrateORPHENADRINE CITRATEUnit Dose ServicesANDACurrent
53002-5430ORPHENADRINE CITRATEORPHENADRINE CITRATERPK Pharmaceuticals, Inc.ANDACurrent
60760-810Orphenadrine CitrateOrphenadrine CitrateSt. Mary's Medical Park PharmacyANDACurrent
60760-810Orphenadrine CitrateOrphenadrine CitrateSt. Mary's Medical Park PharmacyANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect RXANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-177Orphenadrine CitrateOrphenadrine CitrateDirect_RxANDACurrent
61919-507ORPHENADRINE CITRATEORPHENADRINE CITRATEDIRECT RXANDACurrent
61919-507ORPHENADRINE CITRATEORPHENADRINE CITRATEDIRECT RXANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63187-122Orphenadrine CitrateOrphenadrine CitrateProficient Rx LPANDACurrent
63629-1564Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch PrepackANDACurrent
63629-1564Orphenadrine CitrateORPHENADRINE CITRATEBryant Ranch PrepackANDACurrent
66267-158Orphenadrine CitrateOrphenadrine CitrateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-158Orphenadrine CitrateOrphenadrine CitrateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-158Orphenadrine CitrateOrphenadrine CitrateNuCare Pharmaceuticals, Inc.ANDACurrent
66336-554Orphenadrine CitrateOrphenadrine CitrateDispensing Solutions, Inc.ANDACurrent
67296-0709Orphenadrine CitrateOrphenadrine CitrateRedPharm Drug, Inc.ANDACurrent
67296-0709Orphenadrine CitrateOrphenadrine CitrateRedPharm Drug, Inc.ANDACurrent
67296-0709Orphenadrine CitrateOrphenadrine CitrateRedPharm Drug, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9138Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9150Orphenadrine CitrateOrphenadrine CitratePreferred Pharmaceuticals, IncANDACurrent
70934-952ORPHENADRINE CITRATEORPHENADRINE CITRATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
80425-0117NorflexOrphenadrine CitrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0117Orphenadrine CitrateOrphenadrine CitrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0117Orphenadrine CitrateOrphenadrine CitrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7605ORIG1998-06-19