FDA.reportPublic FDA data

Phentermine hydrochloride

Product NDC
71335-0646
11-digit product format
713350646
Labeler code
71335
Product ID
71335-0646_1b4cff1c-1c47-4331-a0d7-c773c5a8f34b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205017
Marketing category
ANDA
Marketing start
2017-01-24
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

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803348

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
71335-0646-0Phentermine hydrochloride56 in 1 BOTTLECAPSULE569
71335-0646-1Phentermine hydrochloride14 in 1 BOTTLECAPSULE149
71335-0646-2Phentermine hydrochloride7 in 1 BOTTLECAPSULE79
71335-0646-3Phentermine hydrochloride30 in 1 BOTTLECAPSULE309
71335-0646-4Phentermine hydrochloride50 in 1 BOTTLECAPSULE509
71335-0646-5Phentermine hydrochloride90 in 1 BOTTLECAPSULE909
71335-0646-6Phentermine hydrochloride120 in 1 BOTTLECAPSULE1209
71335-0646-7Phentermine hydrochloride21 in 1 BOTTLECAPSULE219
71335-0646-8Phentermine hydrochloride28 in 1 BOTTLECAPSULE289
71335-0646-9Phentermine hydrochloride60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0646-0EA - Each71335-0646151d35a3-0b6d-40a9-a80c-7ed3400cd10a12023-01-09
71335-0646-1EA - Each71335-0646e55d2d0f-ad6a-4f37-a028-87b45cda435a12023-01-09
71335-0646-2EA - Each71335-06468896afce-f73c-4bbf-a3ac-afd70269ff7712023-01-09
71335-0646-3EA - Each71335-0646bcee6149-80e6-4a1e-b21c-e2621f3f03a412022-11-07
71335-0646-8EA - Each71335-0646330fad14-e5ad-49a1-8a6f-384f1e44e5a212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0646PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20250221_86a6ce50-673d-4031-87a0-51965cc1e795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSN86a6ce50-673d-4031-87a0-51965cc1e7959
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD86a6ce50-673d-4031-87a0-51965cc1e7959
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY86a6ce50-673d-4031-87a0-51965cc1e7959

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0646-07133506460056 CAPSULE in 1 BOTTLE (71335-0646-0) 56 capsule2018-12-170000-00-00NoNoCurrent
71335-0646-17133506460114 CAPSULE in 1 BOTTLE (71335-0646-1) 14 capsule2018-02-120000-00-00NoNoCurrent
71335-0646-2713350646027 CAPSULE in 1 BOTTLE (71335-0646-2) 7 capsule2018-07-060000-00-00NoNoCurrent
71335-0646-37133506460330 CAPSULE in 1 BOTTLE (71335-0646-3) 30 capsule2018-02-120000-00-00NoNoCurrent
71335-0646-47133506460450 CAPSULE in 1 BOTTLE (71335-0646-4) 50 capsule2025-01-280000-00-00NoNoCurrent
71335-0646-57133506460590 CAPSULE in 1 BOTTLE (71335-0646-5) 90 capsule2025-01-280000-00-00NoNoCurrent
71335-0646-671335064606120 CAPSULE in 1 BOTTLE (71335-0646-6) 120 capsule2025-01-280000-00-00NoNoCurrent
71335-0646-77133506460721 CAPSULE in 1 BOTTLE (71335-0646-7) 21 capsule2025-01-280000-00-00NoNoCurrent
71335-0646-87133506460828 CAPSULE in 1 BOTTLE (71335-0646-8) 28 capsule2020-02-240000-00-00NoNoCurrent
71335-0646-97133506460960 CAPSULE in 1 BOTTLE (71335-0646-9) 60 capsule2025-01-280000-00-00NoNoCurrent