FDA.reportPublic FDA data

Application 061737

Type
ANDA
Sponsor
X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIBA-RXBACITRACIN ZINCPOWDER;FOR RX COMPOUNDING500,000 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
A061737-001ZIBA-RXBACITRACIN ZINC500,000 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 UTC2022-10A061737-001ZIBA-RX500,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061737-001ZIBA-RX500,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061737-001ZIBA-RX500,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061737-001ZIBA-RX500,000 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 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsName fallback
generic name: BACITRACIN ZINC
ClaravieBACITRACIN ZINCGentell LLC59c5a363-6d79-d07e-e063-6294a90a87532026-08-24WarningsName fallback
generic name: BACITRACIN ZINC
Medpride First AidBACITRACIN ZINCShield Line LLCe6a6fb0f-5ab7-4647-84a0-7b9948eed3032026-08-18WarningsName fallback
generic name: BACITRACIN ZINC
Dealmed BacitracinBACITRACIN ZINCDealmed Medical Supplies, LLC.26f282b5-b3af-4049-93f6-659071be721d2026-08-12WarningsName fallback
generic name: BACITRACIN ZINC
Bacitracin ZincBACITRACIN ZINCA-S Medication Solutions9fcda25b-3940-4028-a8ee-6e6c6e4b2a532026-08-07WarningsName fallback
generic name: BACITRACIN ZINC
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsName fallback
generic name: BACITRACIN ZINC
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Inc560ba2ca-ad0f-9202-e063-6294a90aaefd2026-07-14WarningsName fallback
generic name: BACITRACIN ZINC
Single Antibiotic with bacitracinBACITRACIN ZINCSafetec of America4ae9a105-e3f9-4015-8844-085e0b34cdb62026-06-25WarningsName fallback
generic name: BACITRACIN ZINC
Bacitracin ZincBACITRACIN ZINCSun Pharmaceutical Industries, Inc.4afdeedf-9cdf-47d6-919f-ea907fda02902026-04-10WarningsName fallback
generic name: BACITRACIN ZINC
FifthPulse Bacitracin ZincBACITRACIN ZINCWeCare Products LLC5c6b3ad8-c158-4cc0-b1ba-b829b5df12842026-04-02WarningsName fallback
generic name: BACITRACIN ZINC
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Incea16e1de-0100-456b-abe6-d33de78221da2025-12-02WarningsName fallback
generic name: BACITRACIN ZINC
Viaderma Care First Aid AntibioticBACITRACIN ZINCVIADERMA DISTRIBUTION INC0f36f396-e479-486c-b047-2760477609e22025-12-01WarningsName fallback
generic name: BACITRACIN ZINC
ElixirBaciShield First AidBACITRACIN ZINCELIXIR HEALTHCARE USA, LLC.15e31a2a-01b5-4598-850f-4d0348086b4b2025-11-12WarningsName fallback
generic name: BACITRACIN ZINC
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC4352c453-a89c-a2b9-e063-6294a90a61f32025-11-11WarningsName fallback
generic name: BACITRACIN ZINC
Bacitracin ZincBACITRACIN ZINCUniversal Distribution Center LLC186b2750-5bf6-1702-e063-6294a90a62b32025-10-30WarningsName fallback
generic name: BACITRACIN ZINC
Gerigentle-Bacitracin zincBACITRACIN ZINCGeri-Gentle Corporation7e36e4d0-eac3-4aa3-81a7-e21c224b1cd42025-10-23WarningsName fallback
generic name: BACITRACIN ZINC
Family Care First AidBACITRACIN ZINCUnited Exchange Corp.df27620e-7312-8082-e053-2995a90aaca62025-10-21WarningsName fallback
generic name: BACITRACIN ZINC
First Aid AntibioticBACITRACIN ZINCMedline Industries, LPf8282204-f9b9-486f-b18b-dc5ba85cce102025-10-09WarningsName fallback
generic name: BACITRACIN ZINC
Viaderma Care First AidBACITRACIN ZINCViaDerma Distribution, Inc.dabb7ce8-3284-4dfc-bc6e-38a691be43c12025-10-02WarningsName fallback
generic name: BACITRACIN ZINC
FifthPulse Bacitracin Zinc 1ozBACITRACIN ZINCFront Pharmaceutical PLC39f994d4-5f41-fb34-e063-6294a90a45ea2025-07-15WarningsName fallback
generic name: BACITRACIN ZINC

Reported adverse events (FAERS/openFDA)#

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