Home NDC 66993-195 Tobramycin Inhalation
Product NDC 66993-195
11-digit product format 669930195
Labeler code 66993
Product ID 66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tobramycin inhalation
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Prasco, LLC
Application NDA201820
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-09-15
Substance TOBRAMYCIN
Active strength 300 mg/4mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [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 42 .
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 N201820-001 BETHKIS TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N201820-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION RLD, RS 2012-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION RLD, RS 2012-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION RLD, RS 2012-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201820-001 BETHKIS 300MG/4ML SOLUTION / INHALATION AN RLD, RS 2012-10-12 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N201820-001 6987094 2022-09-22 Drug product 2013-01-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N201820-001 7696178 2022-09-22 Drug product 2013-01-30 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N201820-001 7939502 2022-06-14 U-1324 2013-01-30 3bdfa0b2c4d7…
Additional Listing Data#
Finished product Yes
Brand name base Tobramycin Inhalation
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOBRAMYCIN 300 mg/4mL
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 1314763 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 66993-195-94 Tobramycin Inhalation 14 in 1 CARTON SOLUTION 14 5 66993-195-94 Tobramycin Inhalation 4 in 1 POUCH SOLUTION 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-195 TOBRAMYCIN INHALATION SOLUTION [PRASCO, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20230223_b5b51665-c427-42b9-bd6e-6e3c06f650e1.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 66993-195-94 66993019594 14 POUCH in 1 CARTON (66993-195-94) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE 14 pouch 2020-09-15 0000-00-00 No No Current