Chlorthalidone

Product NDC: 16714-800
Requested package NDC: 16714-800-01
11-digit product format: 167140800
Labeler code: 16714
Product ID: 16714-800_eeb7d799-0912-e4be-e053-2995a90ae36c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA089286
Marketing category: ANDA
Marketing start: 2018-04-04
Marketing end: 2022-12-31
Substance: CHLORTHALIDONE
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-800	16714-800-01	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A089286-001	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		1986-07-21
A089286-002	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		1986-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A089286-001	AB
A089286-002	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A089286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A089286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A089286-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089286-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A089286-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089286-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A089286-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83fe98fe-2a14-448c-9029-41f7600d1b0a	Product name	1	20260105
0450926f-f624-49c2-83be-42807e8fbcd5	Product name	1	20251113
8525e779-537f-e5cc-2515-089ecce5f50f	Product name	9	20221128
faf41ef3-b4b3-a29e-3b26-07c3009003bf	Product name	5	20220517
3f5e2da3-8b99-f714-3261-2c998ee07b05	Product name	1	20140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5c	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-800-01	EA - Each	16714-800	29f2e6a7-d04a-4a32-b55a-83b649bce9e4	1	2018-06-11

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Major Pharmaceuticals	2de92cea-8f03-4af0-9d91-d4578510cc53	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	6e5cc0d8-6575-4675-bd8b-9a21b206aae1	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	American Health Packaging	b1ff748d-36e9-4327-aa8a-e8fb22a9d637	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	PD-Rx Pharmaceuticals, Inc.	08b7ee65-53a5-ffbb-e063-6294a90ad4ee	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	Sun Pharmaceutical Industries, Inc.	a304de67-cd2b-4933-937e-4eeecf6cda40	2022-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	dea660bd-d4cc-4c5b-9c6d-674a6dc1c9c2	2021-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	5ea42479-84f4-434d-b65b-de34a7a57926	2017-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q0MQD1073Q	CHLORTHALIDONE	77-36-1	CHLORTHALIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197499	chlorthalidone 25 MG Oral Tablet	PSN	4ca4520e-fc27-4ec4-aa58-afefec2d0f40	4
197499	chlorthalidone 25 MG Oral Tablet	SCD	4ca4520e-fc27-4ec4-aa58-afefec2d0f40	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-800-01	16714080001	100 TABLET in 1 BOTTLE (16714-800-01)	100 tablet	2018-04-04	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorthalidone Tablets USP 25mg and 50mg	Northstar Rx LLC \| Frontida BioPharm Inc.	2022-11-30	HUMAN PRESCRIPTION DRUG LABEL	3
Chlorthalidone Tablets USP 25mg and 50mg	A-S Medication Solutions	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	4