Phentermine Hydrochloride

Product NDC
63187-512
11-digit product format
631870512
Labeler code
63187
Product ID
63187-512_06a2ca7c-6074-40d3-a5de-b26c64a8990a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 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
968766Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a3259ec-ded3-427f-843d-928d130de3daAvailable 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
63187-512-07Phentermine Hydrochloride7 in 1 BOTTLECAPSULE74
63187-512-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE304
63187-512-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE604
63187-512-90Phentermine Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-512-07EA - Each63187-512bece62f5-af79-42e1-b236-282395220fc412017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-512PHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20200320_3a3259ec-ded3-427f-843d-928d130de3da.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
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
ndc (product): 63187-512

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN3a3259ec-ded3-427f-843d-928d130de3da4
968766phentermine hydrochloride 15 MG Oral CapsuleSCD3a3259ec-ded3-427f-843d-928d130de3da4
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY3a3259ec-ded3-427f-843d-928d130de3da4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-512-07631870512077 CAPSULE in 1 BOTTLE (63187-512-07) 7 capsule2017-05-010000-00-00NoNoCurrent
63187-512-306318705123030 CAPSULE in 1 BOTTLE (63187-512-30) 30 capsule2017-05-080000-00-00NoNoCurrent
63187-512-606318705126060 CAPSULE in 1 BOTTLE (63187-512-60) 60 capsule2017-05-010000-00-00NoNoCurrent
63187-512-906318705129090 CAPSULE in 1 BOTTLE (63187-512-90) 90 capsule2017-05-010000-00-00NoNoCurrent