Alprazolam

Product NDC: 43063-609
Requested package NDC: 43063-609-40
11-digit product format: 430630609
Labeler code: 43063
Product ID: 43063-609_2f3aacb7-ebbb-e49e-e063-6394a90a9176
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA074112
Marketing category: ANDA
Marketing start: 1995-12-29
Marketing end: 2027-03-19
Substance: ALPRAZOLAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074112-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29
A074112-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29
A074112-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074112-001	AB
A074112-002	AB
A074112-003	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 4 · 123 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	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A074112-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074112-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074112-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074112-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074112-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 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): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	0ffcdbab-17e4-4395-8155-5b6ad00be6c2	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112 ndc (package): 43063-609-40 ndc (product): 43063-609 ndc11 (package): 43063060940
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	f667458d-ddda-4e9e-e053-2995a90adb5a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	REMEDYREPACK INC.	563e09db-2f3d-4ce8-b356-ae44477be6d0	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Advanced Rx Pharmacy of Tennessee, LLC	b39e2bc8-b691-0f4e-e053-2995a90a00fd	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Sandoz Inc	d9b0e228-17cf-40d7-b62e-5050311c571c	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	f95f4030-e8e0-416f-951d-c4dac09f386a	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	54c790c5-2e6c-439d-8e3b-7502c962a596	2023-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Proficient Rx LP	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Proficient Rx LP	447efe78-3696-481c-bbae-23199a39ec94	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112

Additional Listing Data#

Finished product: Yes
Brand name base: Alprazolam

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YU55MQ3IZY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197321	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
0ffcdbab-17e4-4395-8155-5b6ad00be6c2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43063-609-30	Alprazolam	30 in 1 BOTTLE, PLASTIC	TABLET	30	26
43063-609-40	Alprazolam	40 in 1 BOTTLE, PLASTIC	TABLET	40	26
43063-609-60	Alprazolam	60 in 1 BOTTLE, PLASTIC	TABLET	60	26
43063-609-90	Alprazolam	90 in 1 BOTTLE, PLASTIC	TABLET	90	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-609-30	EA - Each	43063-609	3a706bb2-c28e-4614-8e14-345ce3a88cde	1	2016-01-13
43063-609-40	EA - Each	43063-609	3916890a-b976-48fc-b0ab-b38ab5723015	1	2016-01-13
43063-609-60	EA - Each	43063-609	22d3e70d-c7f0-42d0-b9ca-5df81f3a71ae	1	2015-11-12
43063-609-90	EA - Each	43063-609	9ea252c8-5224-4c1a-8a39-5cfba3008082	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-609	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	26	Current NDC, Legacy NDC, 4 package rows	20250303_0ffcdbab-17e4-4395-8155-5b6ad00be6c2.zip

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
197321	ALPRAZolam 1 MG Oral Tablet	PSN	0ffcdbab-17e4-4395-8155-5b6ad00be6c2	26
197321	alprazolam 1 MG Oral Tablet	SCD	0ffcdbab-17e4-4395-8155-5b6ad00be6c2	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-609-40	43063060940	40 TABLET in 1 BOTTLE, PLASTIC (43063-609-40)	40 tablet	2015-10-19	2027-03-19	No	No	Current