Alprazolam

Product NDC
49884-214
11-digit product format
498840214
Labeler code
49884
Product ID
49884-214_38e94d5e-f7e2-4349-94f2-2fba605f5ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA078088
Marketing category
ANDA
Marketing start
2009-01-09
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 42.

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
A078088-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09
A078088-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09
A078088-003ALPRAZOLAMALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-09
A078088-004ALPRAZOLAMALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078088-001AB
A078088-002AB
A078088-003AB
A078088-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09caaa826d4ba7…
2026-08-18 06:07:402026-07A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09caaa826d4ba7…
2026-08-18 06:07:402026-07A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-09caaa826d4ba7…
2026-08-18 06:07:402026-07A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-001ALPRAZOLAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-002ALPRAZOLAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-003ALPRAZOLAM1MGTABLET, ORALLY DISINTEGRATING / ORALABRS2009-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-004ALPRAZOLAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2009-01-09d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078088-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078088-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078088-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078088-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078088-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078088-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078088-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078088-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078088-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078088-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078088-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078088-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078088-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078088-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078088-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078088-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078088-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078088-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078088-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM2 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
485413Internal RxNorm lookup
485414Internal RxNorm lookup
485415Internal RxNorm lookup
485416Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff1630b4-2044-433c-96bc-0bb4ae8d42a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
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
49884-214-74Alprazolam10 in 1 CARTONTABLET, ORALLY DISINTEGRATING1022
49884-214-74Alprazolam10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-214-74EA - Each49884-214557f46bd-ad9c-472d-a7cc-5cdd37eae5f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
VANILLININACTIVE INGREDIENTCHI530446XALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-214ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ENDO USA, INC.]20Current NDC, Legacy NDC, 2 package rows20250109_ff1630b4-2044-433c-96bc-0bb4ae8d42a0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMPar Health USA, LLCff1630b4-2044-433c-96bc-0bb4ae8d42a02026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078088
application number: ANDA078088
ndc (product): 49884-214
Alprazolam ODT C-IVALPRAZOLAM ODT C-IVDirect_Rx3cf95203-c8b4-9f06-e063-6394a90abc9c2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078088
application number: ANDA078088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485413ALPRAZolam 0.25 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485415ALPRAZolam 0.5 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485414ALPRAZolam 1 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485416ALPRAZolam 2 MG Disintegrating Oral TabletPSNff1630b4-2044-433c-96bc-0bb4ae8d42a022
485413alprazolam 0.25 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022
485415alprazolam 0.5 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022
485414alprazolam 1 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022
485416alprazolam 2 MG Disintegrating Oral TabletSCDff1630b4-2044-433c-96bc-0bb4ae8d42a022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-214-744988402147410 BLISTER PACK in 1 CARTON (49884-214-74) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2009-01-090000-00-00NoNoCurrent