FDA.reportPublic FDA data

Phentermine

Product NDC
17224-890
Requested package NDC
17224-890-56
11-digit product format
172240890
Labeler code
17224
Product ID
17224-890_3389935b-316a-971a-e063-6394a90abaff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
Application
ANDA040887
Marketing category
ANDA
Marketing start
2012-08-15
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040887-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040887-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040887-001PHENTERMINE HYDROCHLORIDE37.5MGCAPSULE / ORALAA2008-04-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040887-001AA1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenterminePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.27e88ebe-6247-4598-8ef2-c882992ed5792026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887
ndc (package): 17224-890-56
ndc (product): 17224-890
ndc11 (package): 17224089056
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutionsea798229-fc2d-417c-9bc9-a3b942f0b64b2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.378d863a-6977-4543-ae50-c3684a6abd9b2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-TECH, Inc.3b44d104-a7d0-4366-9d42-63f784f3cb222024-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040887
application number: ANDA040887

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K2I505OTVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
803348Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27e88ebe-6247-4598-8ef2-c882992ed579Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17224-890-14Phentermine14 in 1 BOTTLECAPSULE143
17224-890-21Phentermine21 in 1 BOTTLECAPSULE213
17224-890-28Phentermine28 in 1 BOTTLECAPSULE283
17224-890-30Phentermine30 in 1 BOTTLECAPSULE303
17224-890-56Phentermine56 in 1 BOTTLECAPSULE563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-890PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [CALVIN SCOTT & CO., INC.]3Current NDC, 5 package rows20250426_27e88ebe-6247-4598-8ef2-c882992ed579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSN27e88ebe-6247-4598-8ef2-c882992ed5794
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD27e88ebe-6247-4598-8ef2-c882992ed5794
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY27e88ebe-6247-4598-8ef2-c882992ed5794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-890-561722408905656 CAPSULE in 1 BOTTLE (17224-890-56) 56 capsule2012-08-15NoNoCurrent