Alprazolam

Product NDC: 71335-1894
11-digit product format: 713351894
Labeler code: 71335
Product ID: 71335-1894_7440d6ab-e47a-4f49-8bf3-0c4cb4a44077
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203346
Marketing category: ANDA
Marketing start: 2015-07-31
Substance: ALPRAZOLAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203346-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31
A203346-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31
A203346-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31
A203346-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203346-001	AB
A203346-002	AB
A203346-003	AB
A203346-004	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 5 · 176 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
2026-10-15 13:18:30	2026-09	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2015-07-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A203346-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203346-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203346-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203346-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203346-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203346-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203346-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203346-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203346-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203346-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203346-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203346-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203346-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203346-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203346-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203346-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203346-004	AB	1	`2680178bc6a6…`

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: Alprazolam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	2 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
197322	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
68d8b8d1-00a4-42c4-a796-90211fee1a6d	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1894-1	Alprazolam	30 in 1 BOTTLE	TABLET	30	104
71335-1894-2	Alprazolam	60 in 1 BOTTLE	TABLET	60	104
71335-1894-3	Alprazolam	90 in 1 BOTTLE	TABLET	90	104
71335-1894-4	Alprazolam	100 in 1 BOTTLE	TABLET	100	104
71335-1894-5	Alprazolam	10 in 1 BOTTLE	TABLET	10	104
71335-1894-6	Alprazolam	120 in 1 BOTTLE	TABLET	120	104
71335-1894-7	Alprazolam	40 in 1 BOTTLE	TABLET	40	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1894-1	EA - Each	71335-1894	d01673ac-74da-4bf9-af08-d4331b7ebab2	1	2026-04-20
71335-1894-2	EA - Each	71335-1894	f35d5de1-854b-405b-92a2-e24a7d6e277d	1	2026-04-20
71335-1894-3	EA - Each	71335-1894	4b578c8f-9cef-48b6-95c8-45c7567b8650	1	2025-03-04
71335-1894-4	EA - Each	71335-1894	578c8cc3-69e0-453f-8691-1400e4b8983a	1	2026-04-20
71335-1894-5	EA - Each	71335-1894	24ea33d5-fe9f-4984-b71b-e9674711a925	1	2026-04-20
71335-1894-6	EA - Each	71335-1894	78f3f68d-fb16-4347-840e-7c51dcc64b7c	1	2026-04-20
71335-1894-7	EA - Each	71335-1894	7e515795-4f0a-4113-9b57-df0e6032dc13	1	2026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1894	ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 7 package rows	20231025_68d8b8d1-00a4-42c4-a796-90211fee1a6d.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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals, Inc.	315b8cf2-01a0-3f7d-e063-6394a90a39b5	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Direct_Rx	f77cfdd0-847d-4edd-e053-6394a90a91b7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	02840ea6-e4a0-96a0-e063-6394a90a19ae	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	American Health Packaging	ea95d182-453b-4c43-8402-d65c488d55f2	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	26f8b63c-6dad-8fac-e063-6394a90a5435	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	f7e63d96-2310-4ab1-e053-6294a90a86fc	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Medsource Pharmaceuticals	14960c0c-555f-acc1-e063-6394a90a232a	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	f9903822-642d-e364-e053-6394a90a22d8	2024-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346
Alprazolam	ALPRAZOLAM	Proficient Rx LP	68e6ef8c-4104-4636-9719-6aa386c892d9	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203346 application number: ANDA203346

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	68d8b8d1-00a4-42c4-a796-90211fee1a6d	104
197322	alprazolam 2 MG Oral Tablet	SCD	68d8b8d1-00a4-42c4-a796-90211fee1a6d	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1894-1	71335189401	30 TABLET in 1 BOTTLE (71335-1894-1)	30 tablet	2021-06-29	0000-00-00	No	No	Current
71335-1894-2	71335189402	60 TABLET in 1 BOTTLE (71335-1894-2)	60 tablet	2021-06-29	0000-00-00	No	No	Current
71335-1894-3	71335189403	90 TABLET in 1 BOTTLE (71335-1894-3)	90 tablet	2021-06-29	0000-00-00	No	No	Current
71335-1894-4	71335189404	100 TABLET in 1 BOTTLE (71335-1894-4)	100 tablet	2021-06-29	0000-00-00	No	No	Current
71335-1894-5	71335189405	10 TABLET in 1 BOTTLE (71335-1894-5)	10 tablet	2021-06-29	0000-00-00	No	No	Current
71335-1894-6	71335189406	120 TABLET in 1 BOTTLE (71335-1894-6)	120 tablet	2021-06-29	0000-00-00	No	No	Current
71335-1894-7	71335189407	40 TABLET in 1 BOTTLE (71335-1894-7)	40 tablet	2021-06-29	0000-00-00	No	No	Current