Atenolol and Chlorthalidone

Product NDC: 70518-2446
11-digit product format: 705182446
Labeler code: 70518
Product ID: 70518-2446_c9386673-a87a-7923-e053-2a95a90a373f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol and Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210028
Marketing category: ANDA
Marketing start: 2019-11-22
Marketing end: 0000-00-00
Substance: ATENOLOL; CHLORTHALIDONE
Active strength: 100 mg/1; mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-2446		D	Discontinued by firm		2026-08-03
excluded package	package	70518-2446	70518-2446-0	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2446-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2446-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2446-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2446-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2446-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2446-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2446-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2446-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2446-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2446-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2446-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2446-0	`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
A210028-001	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2019-03-08
A210028-002	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2019-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210028-001	AB
A210028-002	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	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`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	A210028-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210028-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210028-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210028-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210028-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210028-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210028-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210028-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210028-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210028-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210028-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210028-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210028-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210028-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210028-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210028-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210028-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210028-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2446-0	2023-03-09	C162847	48780-1	f386c649-ad58-0266-e053-dadaa90a7c1a	Atenolol and Chlorthalidone Tablets, USP

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Zydus Lifesciences Limited	a16d6010-a67d-4081-b2a3-ecef9f0f09ea	2024-11-25		Exact identifier application applno (ANDA): 210028 application number: ANDA210028
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Northstar Rx LLC.	1494d5f7-8620-46da-8bca-69b76cd17635	2024-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210028 application number: ANDA210028
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Zydus Pharmaceuticals USA Inc.	69131547-f554-4980-b54e-007afc2c696e	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210028 application number: ANDA210028

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50VV3VW0TI	ATENOLOL	29122-68-7	ATENOLOL
Q0MQD1073Q	CHLORTHALIDONE	77-36-1	CHLORTHALIDONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2446-0	70518244600	90 TABLET in 1 BOTTLE, PLASTIC (70518-2446-0)	90 tablet	2019-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol and Chlorthalidone Tablets, USP	REMEDYREPACK INC.	2023-03-09	HUMAN PRESCRIPTION DRUG LABEL	4