Home NDC 62135-550 Isoniazid
Product NDC 62135-550
11-digit product format 621350550
Labeler code 62135
Product ID 62135-550_44fdc5f6-d8fc-49a1-e063-6394a90ad33c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isoniazid
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA081118
Marketing category ANDA
Marketing start 1997-07-21
Substance ISONIAZID
Active strength 50 mg/5mL
Pharmacologic classes Antimycobacterial [EPC]
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 A081118-001 ISONIAZID ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081118-001 AA
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 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Isoniazid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISONIAZID 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V83O1VOZ8L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105292 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 62135-550-47 Isoniazid 473 mL in 1 BOTTLE SOLUTION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-550 ISONIAZID SOLUTION [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20230520_8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c.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 Sample Exclude flag Status 62135-550-47 62135055047 473 mL in 1 BOTTLE (62135-550-47) 473 ml 2023-05-10 No No Current