Application 050606

Type: NDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 125MG BASE	Yes	No
002	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 250MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050606-001	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15
N050606-002	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N050606-001	AB
N050606-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050606-001	VANCOCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	RLD	1986-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050606-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	RLD, RS	1986-04-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050606-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050606-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050606-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050606-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050606-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050606-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050606-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050606-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050606-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050606-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050606-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050606-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050606-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050606-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050606-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050606-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050606-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050606-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050606-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050606-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050606-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050606-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050606-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050606-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050606-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050606-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050606-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050606-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050606-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050606-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050606-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050606-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050606-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050606-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050606-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	3707ad2e-5c82-4111-a370-e518e5e7e4c5	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050606 application number: NDA050606 ndc (product): 62559-390 ndc (product): 62559-391
Vancocin	VANCOMYCIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	a078d9c2-f89c-4f9f-8ded-60ffb2983c3f	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050606 application number: NDA050606 ndc (product): 62559-311 ndc (product): 62559-310
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Redpharm Drug	3745b502-c222-e307-e063-6394a90a697e	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050606 application number: NDA050606
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	33127951-1fad-15c1-e063-6294a90a6996	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050606 application number: NDA050606

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-310	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-310	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-310	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-310	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-310	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-311	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-311	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-311	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-311	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-311	Vancocin	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-390	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-390	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-390	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-390	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-390	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-391	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-391	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-391	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-391	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-391	vancomycin hydrochloride	vancomycin hydrochloride	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69785	SUPPL	2021-12-27
69761	SUPPL	2021-12-27
66044	SUPPL	2021-02-01
66030	SUPPL	2021-02-01
64268	SUPPL	2020-08-12
64265	SUPPL	2020-08-12
7878	SUPPL	2011-12-15
39035	SUPPL	2011-12-14
30159	SUPPL	2010-01-14
39034	SUPPL	2004-06-01
30158	SUPPL	2004-06-01
30157	SUPPL	2004-03-24
7877	SUPPL	2002-05-24