Phentermine Hydrochloride

Product NDC
71335-1591
11-digit product format
713351591
Labeler code
71335
Product ID
71335-1591_960278a8-2bb7-4231-afcd-f9563c604f10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202248
Marketing category
ANDA
Marketing start
2012-02-17
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1591DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-0DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-1DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-2DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-3DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-4DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-5DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-6DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-7DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-8DDiscontinued by firm2026-08-07
excluded packagepackage71335-159171335-1591-9DDiscontinued by firm2026-08-07

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
A202248-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28
A202248-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202248-001AA
A202248-002AA

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 UTC2026-02A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28782e0a99824c…

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 UTC2026-02A202248-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202248-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202248-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202248-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202248-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202248-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202248-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202248-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202248-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202248-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202248-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202248-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202248-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202248-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202248-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202248-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202248-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202248-002AA1782e0a99824c…

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
71335-1591-0Phentermine Hydrochloride24 in 1 BOTTLECAPSULE243
71335-1591-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE303
71335-1591-2Phentermine Hydrochloride7 in 1 BOTTLECAPSULE73
71335-1591-3Phentermine Hydrochloride14 in 1 BOTTLECAPSULE143
71335-1591-4Phentermine Hydrochloride56 in 1 BOTTLECAPSULE563
71335-1591-5Phentermine Hydrochloride60 in 1 BOTTLECAPSULE603
71335-1591-6Phentermine Hydrochloride2 in 1 BOTTLECAPSULE23
71335-1591-7Phentermine Hydrochloride21 in 1 BOTTLECAPSULE213
71335-1591-8Phentermine Hydrochloride28 in 1 BOTTLECAPSULE283
71335-1591-9Phentermine Hydrochloride42 in 1 BOTTLECAPSULE423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1591PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 10 package rows20240823_039db899-0f3c-4634-95ad-7fa915fe7043.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b425840f-380e-42bd-852a-6ee3641977ce2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke48feec6-50c9-4ccd-b9da-56956d14c8532026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1149f69d-65df-6a98-e063-6394a90aeaa42026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd76940d3-95e6-442d-99ef-4fe92de7a3762025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPrecision Dose Inc.095a2be5-721e-46e6-976f-9137c855cd222025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack723c37c4-868f-40f0-b74d-137dcbb93f9f2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions8c7c1391-bfd1-48f9-b249-9729fe648b892023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN039db899-0f3c-4634-95ad-7fa915fe70433
900038phentermine hydrochloride 30 MG Oral CapsuleSCD039db899-0f3c-4634-95ad-7fa915fe70433
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY039db899-0f3c-4634-95ad-7fa915fe70433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1591-07133515910024 CAPSULE in 1 BOTTLE (71335-1591-0) 24 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-17133515910130 CAPSULE in 1 BOTTLE (71335-1591-1) 30 capsule2020-05-080000-00-00NoNoCurrent
71335-1591-2713351591027 CAPSULE in 1 BOTTLE (71335-1591-2) 7 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-37133515910314 CAPSULE in 1 BOTTLE (71335-1591-3) 14 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-47133515910456 CAPSULE in 1 BOTTLE (71335-1591-4) 56 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-57133515910560 CAPSULE in 1 BOTTLE (71335-1591-5) 60 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-6713351591062 CAPSULE in 1 BOTTLE (71335-1591-6) 2 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-77133515910721 CAPSULE in 1 BOTTLE (71335-1591-7) 21 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-87133515910828 CAPSULE in 1 BOTTLE (71335-1591-8) 28 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-97133515910942 CAPSULE in 1 BOTTLE (71335-1591-9) 42 capsule2024-08-120000-00-00NoNoCurrent