Alprazolam

Product NDC
68071-5243
11-digit product format
680715243
Labeler code
68071
Product ID
68071-5243_e80466c7-3132-1e86-e053-2a95a90a2ebc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207507
Marketing category
ANDA
Marketing start
2018-07-09
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
0 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-5243DDiscontinued by firm2026-10-15
excluded packagepackage68071-524368071-5243-3DDiscontinued by firm2026-10-15

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5243-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5243-3f5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207507-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORAL2018-07-09
A207507-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORAL2018-07-09
A207507-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORAL2018-07-09
A207507-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORAL2018-07-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-09c2088c7a36db…
2026-10-15 13:18:302026-09A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-09c2088c7a36db…
2026-10-15 13:18:302026-09A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-09c2088c7a36db…
2026-10-15 13:18:302026-09A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-09c2088c7a36db…
2026-09-14 22:38:342026-08A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-0984e616aacf4f…
2026-08-18 06:07:402026-07A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-092680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207507-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207507-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207507-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207507-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207507-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207507-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207507-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207507-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207507-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A207507-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A207507-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A207507-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207507-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A207507-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A207507-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A207507-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207507-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207507-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207507-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207507-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207507-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A207507-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A207507-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A207507-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207507-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A207507-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A207507-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A207507-004AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207507-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207507-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207507-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207507-004AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5243-32022-02-07C16284748780-1d6a99b39-8a6e-a426-e053-dadaa90af4c2Alprazolam Tablets, USP CIV
68071-5243-32022-01-28C16284748780-1d6a99b39-8a6e-a426-e053-dadaa90af4c2Alprazolam Tablets, USP CIV

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5243ALPRAZOLAM TABLET [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC20240822_a45ba448-d77b-7bfd-e053-2a95a90aa44b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5243-36807152430330 TABLET in 1 BOTTLE (68071-5243-3) 30 tablet2020-04-280000-00-00NoNoCurrent