Home NDC 60505-6098-1 Tigecycline
Product NDC 60505-6098
Requested package NDC 60505-6098-1
11-digit product format 605056098
Labeler code 60505
Product ID 60505-6098_d4e75cae-c197-e995-7903-2d41c6c1371d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIGECYCLINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Apotex Corp
Application ANDA204439
Marketing category ANDA
Marketing start 2019-04-09
Substance TIGECYCLINE
Active strength 50 mg/5mL
Pharmacologic classes Tetracycline-class Antibacterial [EPC], Tetracyclines [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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204439-001 TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204439-001 AP
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204439-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2018-12-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tigecycline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIGECYCLINE 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70JE2N95KR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 581531 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-6098-1 Tigecycline 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 12 60505-6098-1 Tigecycline 5 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 5 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6098 TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP] 11 Current NDC, Legacy NDC, 2 package rows 20250507_230484a8-408c-dcc1-d0c4-d9dd9a46831b.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-6098-1 60505609801 10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) / 5 mL in 1 VIAL, SINGLE-USE 2019-04-09 0000-00-00 No No Current