FDA.reportPublic FDA data

Application 061580

Type
ANDA
Sponsor
X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACI-RXBACITRACINPOWDER;FOR RX COMPOUNDING5,000,000 UNITS/BOTNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A061580-001BACI-RXBACITRACIN5,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A061580-001BACI-RX5,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061580-001BACI-RX5,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061580-001BACI-RX5,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061580-001BACI-RX5,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982a50c72e98297…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2026-08-03WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINAlderMed Inc.3f0eb4a0-f7bf-45f7-8885-92c65a4bd8992026-06-08WarningsName fallback
generic name: BACITRACIN
Medi-First Bacitracin ZincBACITRACINUnifirst First Aid Corporation54609a4f-0fe9-b750-e063-6394a90ae9ce2026-05-26WarningsName fallback
generic name: BACITRACIN
first aid antibioticBACITRACINHyVee Inc97c87111-260a-48d0-92cd-e22f55a48c7d2026-05-12WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINPreferred Pharmaceuticals, Inc5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd92026-03-16WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsName fallback
generic name: BACITRACIN
Zapotol BacitracinBACITRACINZapatol Corp.c8704895-8819-49ac-8baa-5b97be1d00aa2025-10-22WarningsName fallback
generic name: BACITRACIN
MediChoice BacitracinBACITRACINO&M HALYARD, INC.78079b94-c6fc-4529-aaad-8186924ecba52025-10-09WarningsName fallback
generic name: BACITRACIN
MediChoice Triple AntibioticBACITRACINO&M HALYARD, INC.8369f399-6f64-4441-be72-1f16c7306c0a2025-10-09WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINRUGBY LABORATORIESaa9f414e-d8de-417d-9ccd-027d5a5f54992025-06-27WarningsName fallback
generic name: BACITRACIN
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsName fallback
generic name: BACITRACIN
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsName fallback
generic name: BACITRACIN
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsName fallback
generic name: BACITRACIN
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsName fallback
generic name: BACITRACIN
BACITRACINBACITRACINCVS Pharmacy15ea4415-943a-4d0a-ac23-5f37cd2cf2062024-10-22WarningsName fallback
generic name: BACITRACIN

Reported adverse events (FAERS/openFDA)#

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