Application 061737

Type: ANDA
Sponsor: X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZIBA-RX	BACITRACIN ZINC	POWDER;FOR RX COMPOUNDING	500,000 UNITS/BOT	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A061737-001	ZIBA-RX	BACITRACIN ZINC	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING		Approved 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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A061737-001	ZIBA-RX	500,000 UNITS/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`f41ea6bd6efb…`

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 2 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Viaderma Care First Aid	BACITRACIN ZINC	ViaDerma Distribution, Inc.	dabb7ce8-3284-4dfc-bc6e-38a691be43c1	2025-10-02	Warnings	Name fallback generic name: BACITRACIN ZINC
FifthPulse Bacitracin Zinc 1oz	BACITRACIN ZINC	Front Pharmaceutical PLC	39f994d4-5f41-fb34-e063-6294a90a45ea	2025-07-15	Warnings	Name fallback generic name: BACITRACIN ZINC
FifthPulse Bacitracin Zinc 4oz	BACITRACIN ZINC	Front Pharmaceutical PLC	39fa0e5f-b794-e1e3-e063-6394a90a4ce3	2025-07-15	Warnings	Name fallback generic name: BACITRACIN ZINC
Live Better Bacitracin Zinc	BACITRACIN ZINC	The Great Atlantic & Pacific Tea Company	6915940c-2eae-445c-ba58-e39d221e9d3d	2025-07-11	Warnings	Name fallback generic name: BACITRACIN ZINC
Bacitracin Zinc	BACITRACIN ZINC	STRATEGIC SOURCING SERVICES LLC	4594948d-1f25-4d3c-a615-9e6edda05a10	2025-07-11	Warnings	Name fallback generic name: BACITRACIN ZINC
Good Neighbor Pharmacy Bacitracin Zinc	BACITRACIN ZINC	AmerisourceBergen	3fb302b5-7273-412c-a2ba-b76183e3f179	2025-07-11	Warnings	Name fallback generic name: BACITRACIN ZINC
TopCare Bacitracin Zinc	BACITRACIN ZINC	Topco Associates LLC	5b59e26d-cc25-49a6-ac8b-f79398e18f2d	2025-07-07	Warnings	Name fallback generic name: BACITRACIN ZINC
First Aid Antibiotic	BACITRACIN ZINC	TARGET Corporation	4d8e7146-9215-417e-93be-af706502cfee	2025-07-07	Warnings	Name fallback generic name: BACITRACIN ZINC
Sion Biotext Bacitracin Zinc	BACITRACIN ZINC	Sion Biotext Medical Ltd	35056345-f325-99e8-e063-6294a90a2d7e	2025-06-12	Warnings	Name fallback generic name: BACITRACIN ZINC
ProCure Bacitracin Zinc	BACITRACIN ZINC	Twin Med LLC	36da7993-7c65-7430-e063-6294a90a0626	2025-06-05	Warnings	Name fallback generic name: BACITRACIN ZINC
Bacitracin	BACITRACIN ZINC	Trifecta Pharmaceuticals USA, LLC.	4a9fe0fa-5549-4e06-e054-00144ff8d46c	2025-05-15	Warnings	Name fallback generic name: BACITRACIN ZINC
Vitastem ULTRA	BACITRACIN ZINC	ViaDerma Distribution, Inc	fd96cc09-8522-44a5-b034-0d30e532410d	2025-04-03	Warnings	Name fallback generic name: BACITRACIN ZINC
Vitastem Ultra First Aid Antibiotic	BACITRACIN ZINC	Viaderma Distribution Inc	e6986bf9-22ea-4484-a709-27bc91c9058d	2025-03-18	Warnings	Name fallback generic name: BACITRACIN ZINC
Single Antibiotic with Bacitracin	BACITRACIN ZINC	Randob Labs Ltd.	2a807f1b-986f-a9ea-e063-6394a90aed25	2024-12-30	Warnings	Name fallback generic name: BACITRACIN ZINC
Premier Value Bacitracin Zinc	BACITRACIN ZINC	Pharmacy Value Alliance LLC	99d789be-aa85-0917-e053-2a95a90acd13	2024-12-20	Warnings	Name fallback generic name: BACITRACIN ZINC
Bacitracin Zinc	BACITRACIN ZINC	Rugby Laboratories	ac3c9897-c812-1360-e053-2a95a90ad591	2024-12-17	Warnings	Name fallback generic name: BACITRACIN ZINC
Major Bacitracin	BACITRACIN ZINC	Major Pharmaceuticals	a23ce772-7078-0a4b-e053-2995a90aff0d	2024-12-17	Warnings	Name fallback generic name: BACITRACIN ZINC
Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	eea0d90c-914b-2624-e053-2a95a90a34c9	2024-12-13	Warnings	Name fallback generic name: BACITRACIN ZINC
Winco Bacitracin Zinc	BACITRACIN ZINC	WinCo Foods, LLC	dcdf647f-fa32-4b72-b714-a77e8e332358	2024-11-21	Warnings	Name fallback generic name: BACITRACIN ZINC
BACITRACIN ZINC	BACITRACIN ZINC	STRATUS PHARMACEUTICALS INC	b2cb3a96-b0ca-42ee-8056-91d5450fb376	2024-10-31	Warnings	Name fallback generic name: BACITRACIN ZINC

Reported adverse events (FAERS/openFDA)#

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