Atenolol

Product NDC: 21695-323
11-digit product format: 216950323
Labeler code: 21695
Product ID: 21695-323_d3e90e8f-d3c9-4c73-975f-206a28e0b103
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA073352
Marketing category: ANDA
Marketing start: 1991-12-27
Marketing end: 0000-00-00
Substance: ATENOLOL
Active strength: 50 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-323		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-323	21695-323-30	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-323	21695-323-60	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-323	21695-323-90	I	Inactivated by FDA	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 2 · 88 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	21695-323-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-323-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-323-60	`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	21695-323-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-323-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-323-60	`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	21695-323-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-323-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-323-60	`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	21695-323-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-323-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-323-60	`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	21695-323-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-323-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-323-60	`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	21695-323-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-323-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-323-60	`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	21695-323-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-323-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-323-60	`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	21695-323-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-323-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-323-60	`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	21695-323-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-323-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-323-60	`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	21695-323-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-323-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-323-60	`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	21695-323-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-323-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-323-60	`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	21695-323-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-323-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-323-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-323-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-323-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-323-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-323-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-323-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-323-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-323-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-323-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-323-60	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A073352-001	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL			1991-12-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073352-001	ATENOLOL	50MG	TABLET / ORAL	1991-12-27	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
faf41ef3-b4b3-a29e-3b26-07c3009003bf	Product name	5	20220517
5eb1a708-d713-e905-0a08-b103c64796f4	Product name	3	20201019

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-323-30	2019-09-24	C162847	48780-1	934fe258-4d01-48b1-e053-8cdaa90a720a	Atenolol Tablets, USP
21695-323-60	2019-09-24	C162847	48780-1	934fe258-4d01-48b1-e053-8cdaa90a720a	Atenolol Tablets, USP
21695-323-90	2019-09-24	C162847	48780-1	934fe258-4d01-48b1-e053-8cdaa90a720a	Atenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-323-30	Atenolol	30 in 1 BOTTLE	TABLET	30	1
21695-323-60	Atenolol	60 in 1 BOTTLE	TABLET	60	1
21695-323-90	Atenolol	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-323-30	EA - Each	21695-323	9927e427-2db6-4d34-b760-77b55122ec7e	1	2012-07-24
21695-323-60	EA - Each	21695-323	3f5f2a31-806b-4b04-afa4-95eb95b32a11	1	2012-07-24
21695-323-90	EA - Each	21695-323	585e2180-d46f-414a-af8e-829fac101970	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-323	ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 3 package rows	20100330_aae36822-9c1b-4600-81d6-da022d56c03e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50VV3VW0TI	ATENOLOL	29122-68-7	ATENOLOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197379	atenolol 100 MG Oral Tablet	PSN	aae36822-9c1b-4600-81d6-da022d56c03e	1
197381	atenolol 50 MG Oral Tablet	PSN	aae36822-9c1b-4600-81d6-da022d56c03e	1
197379	atenolol 100 MG Oral Tablet	SCD	aae36822-9c1b-4600-81d6-da022d56c03e	1
197381	atenolol 50 MG Oral Tablet	SCD	aae36822-9c1b-4600-81d6-da022d56c03e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-323-30	21695032330	30 in 1 BOTTLE	Historical
21695-323-60	21695032360	60 in 1 BOTTLE	Historical
21695-323-90	21695032390	90 in 1 BOTTLE	Historical