Phentermine Hydrochloride

Product NDC
71335-0678
11-digit product format
713350678
Labeler code
71335
Product ID
71335-0678_581321c1-c496-4931-92e3-6fe7e3e965be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
30 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040886-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31
A040886-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040886-001AA
A040886-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040886-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040886-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040886-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040886-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040886-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040886-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040886-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040886-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040886-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040886-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040886-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040886-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040886-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040886-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040886-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040886-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040886-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040886-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE30 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
900038Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f1c3a5d-dd9b-4441-a483-aa5777f8e40cAvailable 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
71335-0678-0Phentermine Hydrochloride24 in 1 BOTTLECAPSULE247
71335-0678-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE307
71335-0678-2Phentermine Hydrochloride7 in 1 BOTTLECAPSULE77
71335-0678-3Phentermine Hydrochloride14 in 1 BOTTLECAPSULE147
71335-0678-4Phentermine Hydrochloride56 in 1 BOTTLECAPSULE567
71335-0678-5Phentermine Hydrochloride60 in 1 BOTTLECAPSULE607
71335-0678-6Phentermine Hydrochloride2 in 1 BOTTLECAPSULE27
71335-0678-7Phentermine Hydrochloride21 in 1 BOTTLECAPSULE217
71335-0678-8Phentermine Hydrochloride28 in 1 BOTTLECAPSULE287
71335-0678-9Phentermine Hydrochloride42 in 1 BOTTLECAPSULE427

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0678PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240601_7f1c3a5d-dd9b-4441-a483-aa5777f8e40c.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.2f3b738f-d66b-40c1-8e69-bcd50bce3e472026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4000c00f-aa6c-4ea5-af0e-149dde3c74db2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f115ad6d-cf62-40e7-89d1-6183a9b5071f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2abc445c-daa8-7326-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions5234cabd-6b3e-404d-a0cd-256ee5fcc8f12025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1fe86035-19ef-4944-ad81-c0167a8e7fec2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b4d847a-fcda-df31-e063-6294a90a0c5e2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack7f1c3a5d-dd9b-4441-a483-aa5777f8e40c2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
ndc (product): 71335-0678
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-Tech, Inc.b963f7bb-fa65-4e28-81c9-282fbe70a6a62024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP3a3259ec-ded3-427f-843d-928d130de3da2020-03-01Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7
900038phentermine hydrochloride 30 MG Oral CapsuleSCD7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY7f1c3a5d-dd9b-4441-a483-aa5777f8e40c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0678-07133506780024 CAPSULE in 1 BOTTLE (71335-0678-0) 24 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-17133506780130 CAPSULE in 1 BOTTLE (71335-0678-1) 30 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-2713350678027 CAPSULE in 1 BOTTLE (71335-0678-2) 7 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-37133506780314 CAPSULE in 1 BOTTLE (71335-0678-3) 14 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-47133506780456 CAPSULE in 1 BOTTLE (71335-0678-4) 56 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-57133506780560 CAPSULE in 1 BOTTLE (71335-0678-5) 60 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-6713350678062 CAPSULE in 1 BOTTLE (71335-0678-6) 2 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-77133506780721 CAPSULE in 1 BOTTLE (71335-0678-7) 21 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-87133506780828 CAPSULE in 1 BOTTLE (71335-0678-8) 28 capsule2024-05-300000-00-00NoNoCurrent
71335-0678-97133506780942 CAPSULE in 1 BOTTLE (71335-0678-9) 42 capsule2024-05-300000-00-00NoNoCurrent