Home NDC 68180-167 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 e64feba35796…2022-09-29 23:25 UTC 2022-09 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL AB 2015-01-28 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL AB 2015-01-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A090439-001 VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE CAPSULE / ORAL 2015-01-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A090439-002 VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE CAPSULE / ORAL 2015-01-28 a50c72e98297…
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 68180-167 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 68180-167-13 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