Home NDC 55150-228 Tigecycline
Product NDC 55150-228
11-digit product format 551500228
Labeler code 55150
Product ID 55150-228_a5262444-a326-478c-a6d6-b515ef3d1219
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tigecycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA206335
Marketing category ANDA
Marketing start 2019-06-11
Substance TIGECYCLINE
Active strength 50 mg/1
Pharmacologic classes Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A206335-001 TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206335-001 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 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206335-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2019-06-11 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIGECYCLINE 50 mg/1
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 55150-228-10 Tigecycline 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 8 55150-228-10 Tigecycline 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-228 TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250430_dd58e0c3-d8a8-4cf2-96f8-9dd08f309579.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 55150-228-10 55150022810 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2019-06-11 0000-00-00 No No Current