Home NDC 64980-303 CHLORTHALIDONE
Product NDC 64980-303
11-digit product format 649800303
Labeler code 64980
Product ID 64980-303_94ef7a73-3872-4d19-bdde-881862337783
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORTHALIDONE
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA206904
Marketing category ANDA
Marketing start 2017-05-17
Marketing end 2027-01-31
Substance CHLORTHALIDONE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206904-001 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 A206904-002 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206904-001 CHLORTHALIDONE 25MG TABLET / ORAL AB 2017-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206904-002 CHLORTHALIDONE 50MG TABLET / ORAL AB 2017-03-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CHLORTHALIDONE Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORTHALIDONE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q0MQD1073Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197499 Internal RxNorm lookup 197500 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-303-01 CHLORTHALIDONE 100 in 1 BOTTLE, PLASTIC TABLET 100 7 64980-303-10 CHLORTHALIDONE 1000 in 1 BOTTLE, PLASTIC TABLET 1000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-303 CHLORTHALIDONE TABLET [RISING PHARMA HOLDINGS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250503_f96b2d0b-a141-4efb-8ccc-c447dfc6024a.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 64980-303-01 64980030301 100 TABLET in 1 BOTTLE, PLASTIC (64980-303-01) 100 tablet 2017-05-17 2027-01-31 No No Current 64980-303-10 64980030310 1000 TABLET in 1 BOTTLE, PLASTIC (64980-303-10) 1000 tablet 2017-05-17 2027-01-31 No No Current