Vibativ

Product NDC: 52118-001
11-digit product format: 521180001
Labeler code: 52118
Product ID: 52118-001_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: telavancin hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Theravance, Inc.
Application: NDA022110
Marketing category: NDA
Marketing start: 2009-11-05
Marketing end: 0000-00-00
Substance: TELAVANCIN HYDROCHLORIDE
Active strength: 15 mg/mL
Pharmacologic classes: Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52118-001		I	Inactivated by FDA		2026-08-11
excluded package	package	52118-001	52118-001-01	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52118-001-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52118-001-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52118-001-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52118-001-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52118-001-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52118-001-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52118-001-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52118-001-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52118-001-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52118-001-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52118-001-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52118-001-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52118-001-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52118-001-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52118-001-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52118-001-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52118-001-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52118-001-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52118-001-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52118-001-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52118-001-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	52118-001-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
N022110-001	VIBATIV	TELAVANCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2009-09-11
N022110-002	VIBATIV	TELAVANCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2009-09-11

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022110-001	7531623	2027-01-01		Drug substance
N022110-002	7531623	2027-01-01		Drug substance

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022110-001	VIBATIV	EQ 250MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2009-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022110-002	VIBATIV	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2009-09-11	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 310 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022110-001	7531623	2027-01-01		Drug substance	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022110-002	7531623	2027-01-01		Drug substance	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022110-001	7531623	2027-01-01		Drug substance	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022110-002	7531623	2027-01-01		Drug substance	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022110-001	7531623	2027-01-01		Drug substance	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022110-002	7531623	2027-01-01		Drug substance	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022110-001	7531623	2027-01-01		Drug substance	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022110-002	7531623	2027-01-01		Drug substance	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022110-001	7531623	2027-01-01		Drug substance	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022110-002	7531623	2027-01-01		Drug substance	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022110-001	7531623	2027-01-01		Drug substance	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022110-002	7531623	2027-01-01		Drug substance	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022110-001	7531623	2027-01-01		Drug substance	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022110-002	7531623	2027-01-01		Drug substance	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022110-001	7531623	2027-01-01		Drug substance	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022110-002	7531623	2027-01-01		Drug substance	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022110-001	7531623	2027-01-01		Drug substance	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022110-002	7531623	2027-01-01		Drug substance	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022110-001	7531623	2027-01-01		Drug substance	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022110-002	7531623	2027-01-01		Drug substance	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022110-001	7531623	2027-01-01		Drug substance	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022110-002	7531623	2027-01-01		Drug substance	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022110-001	7531623	2027-01-01		Drug substance	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022110-002	7531623	2027-01-01		Drug substance	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022110-001	7531623	2027-01-01		Drug substance	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022110-002	7531623	2027-01-01		Drug substance	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022110-001	7531623	2027-01-01		Drug substance	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022110-002	7531623	2027-01-01		Drug substance	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-001	6858584	2022-08-24		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-001	6635618	2023-09-11	U-728	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-001	7531623	2027-01-01		Drug substance	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-002	6858584	2022-08-24		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-002	6635618	2023-09-11	U-728	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022110-002	7531623	2027-01-01		Drug substance	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022110-001	6858584	2022-08-24		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022110-001	6635618	2023-09-11	U-728	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022110-001	7531623	2027-01-01		Drug substance	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022110-002	6858584	2022-08-24		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022110-002	6635618	2023-09-11	U-728	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022110-002	7531623	2027-01-01		Drug substance	`5d02ea3f76ae…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52118-001-01	2020-01-31	C162847	48780-1	9d75b9d0-7b91-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VIBATIV ® (telavancin) safely and effectively. See full prescribing information for VIBATIV. VIBATIV ® (telavancin) for injection, for intravenous use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52118-001-01	Vibativ	50 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	50		9
52118-001-01	Vibativ	1 in 1 CONTAINER	INJECTION, POWDER, LYOPHILIZED,	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52118-001-01	EA - Each	52118-001	676fe1c2-57fb-4f7f-9ac7-7c21be29656a	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
telavancin hydrochloride	ACTIVE INGREDIENT	0701472ZG0	VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.]	9
telavancin	ACTIVE MOIETY	XK134822Z0	VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.]	9
Hydroxypropylbetadex (0.58-0.68 MS)	INACTIVE INGREDIENT	1I96OHX6EK	VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.]	9
mannitol	INACTIVE INGREDIENT	3OWL53L36A	VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52118-001	VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.]	9	Legacy NDC, 2 package rows	20140402_9fc67b76-9ba1-45ec-9749-ca3f3a6477d9.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIBATIV	TELAVANCIN HYDROCHLORIDE	Cumberland Pharmaceuticals Inc.	5359b759-db7c-4672-9e8a-59c93869bd91	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022110 application number: NDA022110

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0701472ZG0	TELAVANCIN HYDROCHLORIDE	560130-42-9	TELAVANCIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1728087	telavancin 250 MG Injection	PSN	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728082	telavancin 750 MG Injection	PSN	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728089	VIBATIV 250 MG Injection	PSN	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728085	VIBATIV 750 MG Injection	PSN	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728089	telavancin 250 MG Injection [Vibativ]	SBD	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728085	telavancin 750 MG Injection [Vibativ]	SBD	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728087	telavancin 250 MG Injection	SCD	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728082	telavancin 750 MG Injection	SCD	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728087	telavancin (as telavancin hydrochloride) 250 MG Injection	SY	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728082	telavancin (as telavancin hydrochloride) 750 MG Injection	SY	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728089	Vibativ 250 MG Injection	SY	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9
1728085	Vibativ 750 MG Injection	SY	9fc67b76-9ba1-45ec-9749-ca3f3a6477d9	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52118-001-01	52118000101	50 mL in 1 VIAL, SINGLE-USE	50 ml	Historical