Alprazolam

Product NDC: 66267-564
Requested package NDC: 66267-564-60
11-digit product format: 662670564
Labeler code: 66267
Product ID: 66267-564_b8a7b0c8-25da-5d2c-e053-2995a90a0006
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA074909
Marketing category: ANDA
Marketing start: 1998-03-25
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	66267-564	66267-564-60	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 1 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A074909-001	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB		1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074909-001	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 · 41 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	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074909-001	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1998-03-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A074909-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074909-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074909-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074909-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074909-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074909-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074909-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074909-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074909-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074909-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074909-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074909-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074909-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074909-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074909-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074909-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074909-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074909-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074909-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074909-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074909-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074909-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074909-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074909-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074909-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074909-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074909-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074909-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074909-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074909-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074909-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074909-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074909-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074909-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074909-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074909-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074909-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074909-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074909-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074909-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0b	Product name	1	20140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797	Product name	1	20140508
d153678e-a3c8-bad8-cfe0-385656dde0e7	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66267-564-30	2023-01-30	C162847	48780-1	f386c649-9f3a-0266-e053-dadaa90a7c1a	Alprazolam Tablets, USP
66267-564-60	2023-01-30	C162847	48780-1	f386c649-9f3a-0266-e053-dadaa90a7c1a	Alprazolam Tablets, USP
66267-564-90	2023-01-30	C162847	48780-1	f386c649-9f3a-0266-e053-dadaa90a7c1a	Alprazolam Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66267-564-30	Alprazolam	30 in 1 BOTTLE	TABLET	30	2
66267-564-60	Alprazolam	60 in 1 BOTTLE	TABLET	60	2
66267-564-90	Alprazolam	90 in 1 BOTTLE	TABLET	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66267-564	ALPRAZOLAM TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 3 package rows	20210112_60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec9.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	3c0cb60f-1c3a-48a6-ad16-f14351548412	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909
Alprazolam	ALPRAZOLAM	Sandoz Inc	d9b0e228-17cf-40d7-b62e-5050311c571c	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	b0000772-2514-45a2-a75d-1bbb13c29989	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909
Alprazolam	ALPRAZOLAM	Proficient Rx LP	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074909 application number: ANDA074909

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YU55MQ3IZY	ALPRAZOLAM	28981-97-7	ALPRAZOLAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197322	ALPRAZolam 2 MG Oral Tablet	PSN	60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec9	2
197322	alprazolam 2 MG Oral Tablet	SCD	60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66267-564-60	66267056460	60 TABLET in 1 BOTTLE (66267-564-60)	60 tablet	2017-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alprazolam Tablets, USP	NuCare Pharmaceuticals,Inc. \| NuCare Pharmceuticals,Inc.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	2