Phentermine Hydrochloride

Product NDC
50090-1679
11-digit product format
500901679
Labeler code
50090
Product ID
50090-1679_a471924e-e01a-4665-9ba1-1eaea935a7ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040876
Marketing category
ANDA
Marketing start
2012-08-15
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
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040876-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040876-001AA

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313f01610625f2…
2019-09-15 20:21 UTC2019-09A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040876-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2008-03-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040876-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040876-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040876-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040876-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040876-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040876-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040876-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040876-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040876-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040876-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040876-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040876-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040876-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040876-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040876-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040876-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040876-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040876-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040876-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040876-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040876-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040876-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040876-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040876-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040876-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040876-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040876-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040876-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040876-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040876-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040876-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040876-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040876-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040876-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040876-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040876-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040876-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040876-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040876-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040876-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 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
803353Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
86ec6b9d-2934-4bad-8a80-0b60e2f912f3Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-1679-02023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-12023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-22023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-32023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-42023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-52023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-62023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-02023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-12023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-22023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-32023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-42023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-52023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-1679-62023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1679-0Phentermine Hydrochloride30 in 1 BOTTLETABLET3021
50090-1679-1Phentermine Hydrochloride45 in 1 BOTTLETABLET4521
50090-1679-2Phentermine Hydrochloride60 in 1 BOTTLETABLET6021
50090-1679-3Phentermine Hydrochloride28 in 1 BOTTLETABLET2821
50090-1679-4Phentermine Hydrochloride7 in 1 BOTTLETABLET721
50090-1679-5Phentermine Hydrochloride14 in 1 BOTTLETABLET1421
50090-1679-6Phentermine Hydrochloride90 in 1 BOTTLETABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1679-0EA - Each50090-1679672c8d50-9463-4b72-92f3-ab9a97db2ea612018-11-06
50090-1679-1EA - Each50090-16799e26436e-f762-4afc-ae51-aa7a404a9c2e12018-08-13
50090-1679-2EA - Each50090-16798a881e99-a37a-4f03-a9ed-4fef73fa852512018-08-13
50090-1679-3EA - Each50090-1679e20fdf51-db56-42bd-b27d-2b9e24d794e412018-08-13
50090-1679-4EA - Each50090-1679dabf6645-4881-46cf-9a62-1d0b11f3716312018-08-13
50090-1679-5EA - Each50090-1679f60da0ac-9965-4c58-b366-cfe1db28f10712018-08-13
50090-1679-6EA - Each50090-1679473e8049-41d1-4432-a536-b11d8012736112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1679PHENTERMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 7 package rows20231227_86ec6b9d-2934-4bad-8a80-0b60e2f912f3.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENorthwind Health Company, LLC5528d9f7-45ad-d323-e063-6394a90a3e092026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions86ec6b9d-2934-4bad-8a80-0b60e2f912f32026-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
ndc (product): 50090-1679
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.68fcc228-5f06-4ece-94f3-59b5b33c33252025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.c4e9ec2e-4660-4442-93d7-c05a16e137b52025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.315b8a94-b7cc-1b47-e063-6294a90a2d392025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab2025-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxd27d8379-aa3c-4688-e053-2995a90a44f62025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack2bd5487d-10da-4ae0-9105-273e1a5efdcb2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-TECH, Inc.3b44d104-a7d0-4366-9d42-63f784f3cb222024-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040876
application number: ANDA040876

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN86ec6b9d-2934-4bad-8a80-0b60e2f912f321
803353phentermine hydrochloride 37.5 MG Oral TabletSCD86ec6b9d-2934-4bad-8a80-0b60e2f912f321
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY86ec6b9d-2934-4bad-8a80-0b60e2f912f321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1679-05009016790030 TABLET in 1 BOTTLE (50090-1679-0) 30 tablet2015-02-030000-00-00NoNoCurrent
50090-1679-15009016790145 TABLET in 1 BOTTLE (50090-1679-1) 45 tablet2015-02-030000-00-00NoNoCurrent
50090-1679-25009016790260 TABLET in 1 BOTTLE (50090-1679-2) 60 tablet2015-02-030000-00-00NoNoCurrent
50090-1679-35009016790328 TABLET in 1 BOTTLE (50090-1679-3) 28 tablet2015-04-280000-00-00NoNoCurrent
50090-1679-4500901679047 TABLET in 1 BOTTLE (50090-1679-4) 7 tablet2015-04-280000-00-00NoNoCurrent
50090-1679-55009016790514 TABLET in 1 BOTTLE (50090-1679-5) 14 tablet2015-04-280000-00-00NoNoCurrent
50090-1679-65009016790690 TABLET in 1 BOTTLE (50090-1679-6) 90 tablet2018-08-060000-00-00NoNoCurrent