VANCOMYCIN HYDROCHLORIDE

Product NDC: 68180-167
11-digit product format: 681800167
Labeler code: 68180
Product ID: 68180-167_edc05613-fa85-489c-8251-80120fabdd7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VANCOMYCIN HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA090439
Marketing category: ANDA
Marketing start: 2015-03-27
Marketing end: 0000-00-00
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68180-167		D	Discontinued by firm		2026-10-05
excluded package	package	68180-167	68180-167-13	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090439-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL			2015-01-28
A090439-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL			2015-01-28

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL		2015-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL		2015-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL		2015-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL		2015-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090439-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2015-01-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090439-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2015-01-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090439-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090439-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090439-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090439-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090439-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090439-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090439-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090439-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090439-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090439-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090439-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090439-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090439-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090439-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090439-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090439-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090439-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090439-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090439-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090439-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090439-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090439-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090439-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090439-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090439-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090439-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090439-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090439-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090439-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090439-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090439-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090439-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090439-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090439-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090439-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090439-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090439-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090439-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090439-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090439-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-167-11	EA - Each	68180-167	6c1dc5e1-48cc-4daf-ab2f-71a60287d4a5	1	2017-03-06
68180-167-13	EA - Each	68180-167	b0b977b1-be7c-4920-8628-aadbcc9bc6e7	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VANCOMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	71WO621TJD	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
VANCOMYCIN	ACTIVE MOIETY	6Q205EH1VU	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-167	VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]	13	Legacy NDC	20231220_20a8f14c-9c90-47f7-98b1-e8c63414cdf0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
71WO621TJD	VANCOMYCIN HYDROCHLORIDE	1404-93-9	VANCOMYCIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-167-13	68180016713	2 BLISTER PACK in 1 CARTON (68180-167-13) > 10 CAPSULE in 1 BLISTER PACK (68180-167-11)	2 blister pack	2015-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VANCOMYCIN HYDROCHLORIDE	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-12-19	HUMAN PRESCRIPTION DRUG LABEL	13