Atenolol and Chlorthalidone

Product NDC: 68788-4156
11-digit product format: 687884156
Labeler code: 68788
Product ID: 68788-4156_c58e12ad-d705-4643-91ac-ff079e9eb28e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol and Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA213302
Marketing category: ANDA
Marketing start: 2026-07-16
Substance: ATENOLOL; CHLORTHALIDONE
Active strength: 100; 25 mg/1; mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide-like Diuretic [EPC], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213302-001	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25
A213302-002	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	RS	2020-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213302-001	AB
A213302-002	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 2 · 76 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
2026-09-14 22:38:34	2026-08	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	RS	2020-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	RS	2020-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213302-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2020-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213302-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2020-11-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213302-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213302-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213302-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213302-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213302-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213302-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213302-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213302-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213302-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213302-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213302-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213302-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213302-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213302-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213302-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213302-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213302-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213302-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213302-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213302-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213302-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213302-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213302-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213302-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213302-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213302-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213302-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213302-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213302-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213302-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213302-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213302-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213302-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213302-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213302-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213302-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213302-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213302-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213302-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213302-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Atenolol and Chlorthalidone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATENOLOL	100 mg/1
CHLORTHALIDONE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
50VV3VW0TI	Internal UNII lookup
Q0MQD1073Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197382	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c58e12ad-d705-4643-91ac-ff079e9eb28e	Available on FDA.report

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	REMEDYREPACK INC.	dfbd0160-f56a-41b9-a4ff-eb2df73b1e9b	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213302 application number: ANDA213302
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	c58e12ad-d705-4643-91ac-ff079e9eb28e	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213302 application number: ANDA213302 ndc (product): 68788-4156
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Unichem Pharmaceuticals (USA), Inc.	a85d28c1-e812-4c12-aa67-136bff3610e5	2024-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213302 application number: ANDA213302

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	Sample	Exclude flag	Status
68788-4156-1	68788415601	100 TABLET in 1 BOTTLE (68788-4156-1)	100 tablet	2026-07-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol and Chlorthalidone Tablets, USP	Preferred Pharmaceuticals Inc.	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	1