Home NDC 67877-678-70 Tobramycin
Product NDC 67877-678
Requested package NDC 67877-678-70
11-digit product format 678770678
Labeler code 67877
Product ID 67877-678_25c12569-0ae1-4117-a945-edfc5457e525
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Ascend Laboratories, LLC
Application ANDA212848
Marketing category ANDA
Marketing start 2021-04-02
Substance TOBRAMYCIN
Active strength 300 mg/5mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 67877-678 67877-678-70 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…
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 A212848-001 TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212848-001 AN
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 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212848-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2021-04-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tobramycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOBRAMYCIN 300 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VZ8RRZ51VK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 348719 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 67877-678-69 Tobramycin 5 mL in 1 AMPULE SOLUTION 5 8 67877-678-69 Tobramycin 7 in 1 POUCH SOLUTION 7 8 67877-678-70 Tobramycin 56 in 1 CARTON SOLUTION 56 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-678 TOBRAMYCIN SOLUTION [ASCEND LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 3 package rows 20240111_845e3328-fffa-44eb-b78a-3607c05fdd55.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 Units Marketing start Marketing end Sample Exclude flag Status 67877-678-70 67877067870 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE 56 pouch 2021-04-02 0000-00-00 No No Current