Home NDC 25021-158 Vancomycin
Product NDC 25021-158
11-digit product format 250210158
Labeler code 25021
Product ID 25021-158_9618e90e-b925-4d13-9e0f-08bb8c663daf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vancomycin hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA200837
Marketing category ANDA
Marketing start 2012-09-20
Substance VANCOMYCIN HYDROCHLORIDE
Active strength 10 g/100mL
Pharmacologic classes Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A200837-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 A200837-002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 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 2026-10-15 13:18:30 2026-09 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200837-001 VANCOMYCIN HYDROCHLORIDE EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2012-08-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200837-002 VANCOMYCIN HYDROCHLORIDE EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-02 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Vancomycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VANCOMYCIN HYDROCHLORIDE 10 g/100mL
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-158-99 Vancomycin 100 mL in 1 BOTTLE INJECTION, POWDER, LYOPHILIZED, 100 14 25021-158-99 Vancomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-158 VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 14 Current NDC, Legacy NDC, 2 package rows 20240725_06dcfd36-942f-4752-86ad-4c5a6fc3e48f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-158-99 25021015899 1 BOTTLE in 1 CARTON (25021-158-99) / 100 mL in 1 BOTTLE 1 bottle 2012-09-20 0000-00-00 No No Current