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 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A061580-001BACI-RX5,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2025-06-20WarningsName 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
BacitracinBACITRACINDynarex Corporation7f8752c7-6839-261d-e053-2991aa0a0c302024-11-20WarningsName 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