Home NDC 71288-019 Tigecycline
Product NDC 71288-019
11-digit product format 712880019
Labeler code 71288
Product ID 71288-019_944a7489-75b7-4841-a189-1bb66fa83e30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tigecycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA214020
Marketing category ANDA
Marketing start 2021-05-13
Substance TIGECYCLINE
Active strength 50 mg/5mL
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 A214020-001 TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214020-001 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.
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 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214020-001 TIGECYCLINE 50MG/VIAL POWDER / INTRAVENOUS AP 2021-05-13 a50c72e98297…
Observed Orange Book normalized TE history# 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/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 71288-019-10 Tigecycline 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 5 71288-019-11 Tigecycline 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 5 71288-019-91 Tigecycline 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 1 71288-019-92 Tigecycline 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-019 TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20210520_4cbefeb0-7d63-4c49-9906-384acc53dd15.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 · 2 matching rows.
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 71288-019-10 71288001910 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 71288-019-11 71288001911 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-10) 2021-05-13 0000-00-00 No No Current 71288-019-91 71288001991 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 71288-019-92 71288001992 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-92) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-91) 2026-04-01 No No Current