FDA.reportPublic FDA data

LOMAIRA

Product NDC
63629-7874
Requested package NDC
63629-7874-2
11-digit product format
636297874
Labeler code
63629
Product ID
63629-7874_05b5a6a3-9edc-4f9f-8b09-7a002fe6c387
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203495
Marketing category
ANDA
Marketing start
2016-09-12
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
8 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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-787463629-7874-2DDiscontinued by firm2026-07-31

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
A203495-001LOMAIRAPHENTERMINE HYDROCHLORIDE8MGTABLET / ORALAARS2016-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203495-001AA

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 22:54:322026-06A203495-001LOMAIRA8MGTABLET / ORALAARS2016-09-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203495-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOMAIRAPHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.0718f0f3-77f2-45d7-be12-1ed718c8b8062026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203495
application number: ANDA203495
LOMAIRAPHENTERMINE HYDROCHLORIDEKVK-TECH, INC.cde9fb09-e5af-434d-8874-e4f9f974d8932023-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203495
application number: ANDA203495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7874-26362978740260 TABLET in 1 BOTTLE (63629-7874-2) 60 tablet2018-12-200000-00-00NoNoCurrent