Atenolol and Chlorthalidone

Product NDC: 16714-936
Requested package NDC: 16714-936-01
11-digit product format: 167140936
Labeler code: 16714
Product ID: 16714-936_8b339301-d620-4dcf-8be7-bb7b09182ec4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol and Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC.
Application: ANDA210028
Marketing category: ANDA
Marketing start: 2019-03-26
Substance: ATENOLOL; CHLORTHALIDONE
Active strength: 50; 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
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 · 86 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
2026-09-14 22:38:34	2026-08	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A210028-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210028-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210028-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210028-002	AB	1	`caaa826d4ba7…`
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…`

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	50 mg/1
CHLORTHALIDONE	25 mg/1

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
8525e779-537f-e5cc-2515-089ecce5f50f	Product name	9	20221128
faf41ef3-b4b3-a29e-3b26-07c3009003bf	Product name	5	20220517
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
5eb1a708-d713-e905-0a08-b103c64796f4	Product name	3	20201019
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3f5e2da3-8b99-f714-3261-2c998ee07b05	Product name	1	20140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-936-01	Atenolol and Chlorthalidone	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-936-01	EA - Each	16714-936	5681cd68-ea9c-4690-ab25-e5d5577c6fa6	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-936	ATENOLOL AND CHLORTHALIDONE TABLET [NORTHSTAR RX LLC.]	3	Current NDC, Legacy NDC, 1 package rows	20240306_1494d5f7-8620-46da-8bca-69b76cd17635.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197382	atenolol 100 MG / chlorthalidone 25 MG Oral Tablet	PSN	1494d5f7-8620-46da-8bca-69b76cd17635	3
197383	atenolol 50 MG / chlorthalidone 25 MG Oral Tablet	PSN	1494d5f7-8620-46da-8bca-69b76cd17635	3
197382	atenolol 100 MG / chlorthalidone 25 MG Oral Tablet	SCD	1494d5f7-8620-46da-8bca-69b76cd17635	3
197383	atenolol 50 MG / chlorthalidone 25 MG Oral Tablet	SCD	1494d5f7-8620-46da-8bca-69b76cd17635	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-936-01	16714093601	100 TABLET in 1 BOTTLE (16714-936-01)	100 tablet	2019-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol and Chlorthalidone Tablets, USP Rx only	Northstar Rx LLC. \| Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2026-10-05	HUMAN PRESCRIPTION DRUG LABEL	4