Home NDC 68180-166 VANCOMYCIN HYDROCHLORIDE
Product NDC 68180-166
11-digit product format 681800166
Labeler code 68180
Product ID 68180-166_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 125 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 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 RLD / RS 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 1 of 2 · 80 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 68180-166 VANCOMYCIN HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 13 Legacy NDC 20231220_20a8f14c-9c90-47f7-98b1-e8c63414cdf0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-166-13 68180016613 2 BLISTER PACK in 1 CARTON (68180-166-13) > 10 CAPSULE in 1 BLISTER PACK (68180-166-11) 2 blister pack 2015-03-27 0000-00-00 No No Current