Alprazolam

Product NDC
0781-1077
11-digit product format
007811077
Labeler code
0781
Product ID
0781-1077_4c8c7366-aa3b-4124-9d64-67fb0ead6e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074112
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
2027-03-19
Substance
ALPRAZOLAM
Active strength
.5 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074112-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29
A074112-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29
A074112-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB1995-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074112-001AB
A074112-002AB
A074112-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074112-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074112-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074112-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074112-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YU55MQ3IZYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197321Internal RxNorm lookup
197322Internal RxNorm lookup
308047Internal RxNorm lookup
308048Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9b0e228-17cf-40d7-b62e-5050311c571cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0bProduct name120140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797Product name120140508
d153678e-a3c8-bad8-cfe0-385656dde0e7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1077-01Alprazolam100 in 1 BOTTLETABLET10021
0781-1077-05Alprazolam500 in 1 BOTTLETABLET50021
0781-1077-10Alprazolam1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1077-01EA - Each0781-107762d5916c-50b8-46d2-96b0-4af7730713ee12012-07-24
0781-1077-05EA - Each0781-10771da64447-e2bb-4ac1-b9f6-0886f54c96a912012-07-24
0781-1077-10EA - Each0781-10779f684a81-58b1-4a3f-97d6-68e61b6883ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM (ALPRAZOLAM) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3217
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [SANDOZ INC]10
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [SANDOZ INC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [SANDOZ INC]10
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [SANDOZ INC]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [SANDOZ INC]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [SANDOZ INC]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [SANDOZ INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [SANDOZ INC]10
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [SANDOZ INC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [SANDOZ INC]10
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CHOLINEACTIVE MOIETYN91BDP6H0XGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
GELATININACTIVE INGREDIENT2G86QN327LGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGABAZOLAMINE-0.5 (ALPRAZOLAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]8
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [REDPHARM]5
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [REDPHARM]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [REDPHARM]5
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [REDPHARM]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [REDPHARM]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [REDPHARM]5
magnesium stearateINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [REDPHARM]5
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [REDPHARM]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [REDPHARM]5
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
starch, cornINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS, INC.]4
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]3
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [DIRECT RX]3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [DIRECT RX]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [DIRECT RX]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [DIRECT RX]3
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]2
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]2
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PROFICIENT RX LP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PROFICIENT RX LP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
AlprazolamACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [STAT RX USA LLC]1
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [STAT RX USA LLC]1
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
AlprazolamACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [STAT RX USA LLC]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [STAT RX USA LLC]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [STAT RX USA LLC]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [UNIT DOSE SERVICES]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [STAT RX USA LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [CONTRACT PHARMACY SERVICES-PA]1
starch, cornINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1077ALPRAZOLAM TABLET [SANDOZ INC]21Current NDC, Legacy NDC, 3 package rows20241122_d9b0e228-17cf-40d7-b62e-5050311c571c.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMA-S Medication Solutions3c0cb60f-1c3a-48a6-ad16-f143515484122025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.0ffcdbab-17e4-4395-8155-5b6ad00be6c22025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCf667458d-ddda-4e9e-e053-2995a90adb5a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMREMEDYREPACK INC.563e09db-2f3d-4ce8-b356-ae44477be6d02024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAdvanced Rx Pharmacy of Tennessee, LLCb39e2bc8-b691-0f4e-e053-2995a90a00fd2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
ndc (product): 0781-1077
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLCf95f4030-e8e0-416f-951d-c4dac09f386a2023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC54c790c5-2e6c-439d-8e3b-7502c962a5962023-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMProficient Rx LP717ce509-f92e-4ec1-a3c6-aeae54d56f4d2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMProficient Rx LP447efe78-3696-481c-bbae-23199a39ec942019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
308048ALPRAZolam 0.5 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
197321ALPRAZolam 1 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
197322ALPRAZolam 2 MG Oral TabletPSNd9b0e228-17cf-40d7-b62e-5050311c571c21
308047alprazolam 0.25 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
308048alprazolam 0.5 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
197321alprazolam 1 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
197322alprazolam 2 MG Oral TabletSCDd9b0e228-17cf-40d7-b62e-5050311c571c21
308048ALPRAZolam 0.5 MG Oral TabletPSNbaf74846-0041-4e87-a6a4-9b5e148f2b5b10
308048alprazolam 0.5 MG Oral TabletSCDbaf74846-0041-4e87-a6a4-9b5e148f2b5b10
308048ALPRAZolam 0.5 MG Oral TabletPSNf420b7ad-a0ae-4936-b7eb-12d347af2ef39
308048alprazolam 0.5 MG Oral TabletSCDf420b7ad-a0ae-4936-b7eb-12d347af2ef39
308048ALPRAZolam 0.5 MG Oral TabletPSNc4b5257a-4dfa-4a58-a05b-c0a32dbb93528
308048alprazolam 0.5 MG Oral TabletSCDc4b5257a-4dfa-4a58-a05b-c0a32dbb93528
308048ALPRAZolam 0.5 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197321ALPRAZolam 1 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197322ALPRAZolam 2 MG Oral TabletPSN717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
308048alprazolam 0.5 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197321alprazolam 1 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
197322alprazolam 2 MG Oral TabletSCD717ce509-f92e-4ec1-a3c6-aeae54d56f4d6
308048ALPRAZolam 0.5 MG Oral TabletPSNbb6708c0-0446-40a9-8b68-a8785c7ab0615
308048alprazolam 0.5 MG Oral TabletSCDbb6708c0-0446-40a9-8b68-a8785c7ab0615
308048ALPRAZolam 0.5 MG Oral TabletPSN5abbc5cd-7c71-467e-ab9b-74ff297784203
308048alprazolam 0.5 MG Oral TabletSCD5abbc5cd-7c71-467e-ab9b-74ff297784203
308047ALPRAZolam 0.25 MG Oral TabletPSN5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308048ALPRAZolam 0.5 MG Oral TabletPSNf95f4030-e8e0-416f-951d-c4dac09f386a2
308048ALPRAZolam 0.5 MG Oral TabletPSNf667458d-ddda-4e9e-e053-2995a90adb5a2
308048ALPRAZolam 0.5 MG Oral TabletPSN5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
197321ALPRAZolam 1 MG Oral TabletPSN5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308047alprazolam 0.25 MG Oral TabletSCD5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308048alprazolam 0.5 MG Oral TabletSCDf667458d-ddda-4e9e-e053-2995a90adb5a2
308048alprazolam 0.5 MG Oral TabletSCD5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308048alprazolam 0.5 MG Oral TabletSCDf95f4030-e8e0-416f-951d-c4dac09f386a2
197321alprazolam 1 MG Oral TabletSCD5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b72
308047ALPRAZolam 0.25 MG Oral TabletPSN366500a0-6e91-4aaf-802a-8966b1c5a3e51
308047ALPRAZolam 0.25 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308048ALPRAZolam 0.5 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308048ALPRAZolam 0.5 MG Oral TabletPSN263d7c02-ca81-4035-9b3e-5104e8aff0861
308048ALPRAZolam 0.5 MG Oral TabletPSN4be7a143-df57-0f39-e054-00144ff88e881
308048ALPRAZolam 0.5 MG Oral TabletPSN6f4678b4-7e1e-4cc6-87b8-effd4f436ad11
308048ALPRAZolam 0.5 MG Oral TabletPSN366500a0-6e91-4aaf-802a-8966b1c5a3e51
197321ALPRAZolam 1 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
197321ALPRAZolam 1 MG Oral TabletPSN263d7c02-ca81-4035-9b3e-5104e8aff0861
197321ALPRAZolam 1 MG Oral TabletPSN366500a0-6e91-4aaf-802a-8966b1c5a3e51
197322ALPRAZolam 2 MG Oral TabletPSNd7a54ceb-2d80-4879-950f-cad3623240861
308047alprazolam 0.25 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
308047alprazolam 0.25 MG Oral TabletSCD366500a0-6e91-4aaf-802a-8966b1c5a3e51
308048alprazolam 0.5 MG Oral TabletSCD263d7c02-ca81-4035-9b3e-5104e8aff0861
308048alprazolam 0.5 MG Oral TabletSCD6f4678b4-7e1e-4cc6-87b8-effd4f436ad11
308048alprazolam 0.5 MG Oral TabletSCD366500a0-6e91-4aaf-802a-8966b1c5a3e51
308048alprazolam 0.5 MG Oral TabletSCD4be7a143-df57-0f39-e054-00144ff88e881
308048alprazolam 0.5 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
197321alprazolam 1 MG Oral TabletSCD263d7c02-ca81-4035-9b3e-5104e8aff0861
197321alprazolam 1 MG Oral TabletSCD366500a0-6e91-4aaf-802a-8966b1c5a3e51
197321alprazolam 1 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861
197322alprazolam 2 MG Oral TabletSCDd7a54ceb-2d80-4879-950f-cad3623240861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1077-0100781107701100 TABLET in 1 BOTTLE (0781-1077-01) 100 tablet1995-12-292027-03-19NoNoCurrent
0781-1077-0500781107705500 TABLET in 1 BOTTLE (0781-1077-05) 500 tablet1995-12-292027-03-19NoNoCurrent
0781-1077-10007811077101000 TABLET in 1 BOTTLE (0781-1077-10) 1000 tablet1995-12-292027-03-19NoNoCurrent