FDA.reportPublic FDA data

Application 080704

Type
ANDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITAMIN DERGOCALCIFEROLCAPSULE;ORAL50,000 IUNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A080704-001VITAMIN DERGOCALCIFEROL50,000 IUCAPSULE / ORALAAApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080704-001AA

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A080704-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A080704-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080704-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080704-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080704-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080704-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080704-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080704-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080704-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080704-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080704-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080704-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080704-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080704-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080704-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080704-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080704-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080704-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080704-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080704-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080704-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080704-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080704-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A080704-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080704-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080704-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080704-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A080704-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080704-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080704-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080704-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080704-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080704-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080704-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080704-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080704-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080704-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080704-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080704-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080704-001AA1f41ea6bd6efb…

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
ErgocalciferolERGOCALCIFEROLREMEDYREPACK INC.a80436e0-b507-4e7b-9a60-a9d5ddc4a0452026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 70518-0177
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack0d230fd8-2ea7-4dd6-a506-5f7804e539fc2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepackc4793165-6647-4dba-b100-3986739cd01e2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 71335-1699
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack39b72d09-cedc-4130-89a3-1ea03f58ba042026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 71335-0062
ErgocalciferolERGOCALCIFEROLSt. Mary's Medical Park Pharmacy5f4ef344-7880-3375-e053-2a91aa0a47b82026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 60760-152
ErgocalciferolERGOCALCIFEROLPD-Rx Pharmaceuticals, Inc.2475e731-0072-4787-8a40-09137883c6252026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 43063-711
ErgocalciferolERGOCALCIFEROLNuCare Pharmaceuticals, Inc.492452d6-2b32-39c0-e054-00144ff8d46c2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 68071-1951
ErgocalciferolERGOCALCIFEROLPreferred Pharmaceuticals Inc.1cd4afc6-ef90-4e7b-9f11-2bfbd137524c2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLAvKAREf55eafcd-dfd9-fdae-c39f-ae07aa852ce12025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 42291-266
ErgocalciferolERGOCALCIFEROLBionpharma Inc.2a8d73d6-9991-401b-ab8b-81f22e5a06952025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 69452-151
Vitamin DVITAMIN DDirectRX84647b52-3c4c-31bb-e053-2991aa0a8a7e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 61919-702
ErgocalciferolERGOCALCIFEROLAphena Pharma Solutions - Tennessee, LLCc538ac91-2507-4f42-8f7a-013510539b302024-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack9e63d720-cce8-4a59-b311-26cfca1139572024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 63629-2447
ErgocalciferolERGOCALCIFEROLAphena Pharma Solutions - Tennessee, LLC2841b0ba-3b09-4f03-a060-9fb7f1af83442018-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 43353-238

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
42291-266ErgocalciferolErgocalciferolAvKARE, Inc.ANDACurrent
42291-266ErgocalciferolErgocalciferolAvKAREANDACurrent
43063-711ErgocalciferolErgocalciferolPD-Rx Pharmaceuticals, InANDACurrent
43063-711ErgocalciferolErgocalciferolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-711ErgocalciferolErgocalciferolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-711ErgocalciferolErgocalciferolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-711ErgocalciferolErgocalciferolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-711ErgocalciferolErgocalciferolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-711ErgocalciferolErgocalciferolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-238ErgocalciferolErgocalciferolAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-4382ErgocalciferolErgocalciferolA-S Medication SolutionsANDACurrent
50090-4382ErgocalciferolErgocalciferolA-S Medication SolutionsANDACurrent
50090-4382ErgocalciferolErgocalciferolA-S Medication SolutionsANDACurrent
60760-152ErgocalciferolErgocalciferolSt. Mary's Medical Park PharmacyANDACurrent
60760-152ErgocalciferolErgocalciferolSt. Mary's Medical Park PharmacyANDACurrent
61919-702Vitamin DVitamin DDirectRXANDACurrent
63629-2447ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
63629-2447ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
63629-6456ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
63629-7942ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
63629-7942ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
63629-8144ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
63629-8144ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
68071-1864ErgocalciferolErgocalciferolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1864ErgocalciferolErgocalciferolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1864ErgocalciferolErgocalciferolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1951ErgocalciferolErgocalciferolNuCare Pharmaceuticals, IANDACurrent
68071-1951ErgocalciferolErgocalciferolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1951ErgocalciferolErgocalciferolNuCare Pharmaceuticals, Inc.ANDACurrent
69387-106ErgocalciferolErgocalciferolBanner Life Sciences LLC.ANDACurrent
69452-151ErgocalciferolErgocalciferolBionpharma Inc.ANDACurrent
69452-151ErgocalciferolErgocalciferolBionpharma Inc.ANDACurrent
70518-0177ErgocalciferolErgocalciferolREMEDYREPACK INC.ANDACurrent
70518-0177ErgocalciferolErgocalciferolREMEDYREPACK INC.ANDACurrent
70518-0177ErgocalciferolErgocalciferolREMEDYREPACK INC.ANDACurrent
70518-0177ErgocalciferolErgocalciferolREMEDYREPACK INC.ANDACurrent
70518-0177ErgocalciferolErgocalciferolREMEDYREPACK INC.ANDACurrent
70518-0177ErgocalciferolErgocalciferolREMEDYREPACK INC.ANDACurrent
70934-252ErgocalciferolErgocalciferolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-252ErgocalciferolErgocalciferolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-252ErgocalciferolErgocalciferolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-252ErgocalciferolErgocalciferolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0062ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
71335-0062ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
71335-1275ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
71335-1275ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
71335-1275ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
71335-1449ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
71335-1449ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent
71335-1699ErgocalciferolErgocalciferolBryant Ranch PrepackANDACurrent