Phentermine Hydrochloride

Product NDC: 53489-676
11-digit product format: 534890676
Labeler code: 53489
Product ID: 53489-676_39e24c57-7266-2bf6-e063-6294a90afdd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA040526
Marketing category: ANDA
Marketing start: 2013-08-12
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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040526-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2003-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040526-001	AA

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040526-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040526-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040526-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040526-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040526-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040526-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040526-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040526-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040526-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040526-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040526-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040526-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040526-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040526-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040526-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040526-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040526-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040526-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040526-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040526-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040526-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040526-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040526-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040526-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040526-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040526-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040526-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040526-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040526-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040526-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040526-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040526-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040526-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040526-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040526-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040526-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040526-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040526-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040526-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040526-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K2I505OTV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
803353	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
02b8f684-b1ca-4ab7-9567-bcacc6a92779	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3d272a3f-17c0-421d-bc43-3cbdb719258d	Product name	1	20250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab	Product name	2	20230717
ebeae3eb-385d-62da-8827-5ffa80b14e90	Product name	2	20170810
1d682039-1122-1cb7-f3f4-c0a028b98748	Product name	4	20170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56	Product name	3	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53489-676-01	Phentermine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100	10
53489-676-03	Phentermine Hydrochloride	250 in 1 BOTTLE, PLASTIC	TABLET	250	10
53489-676-05	Phentermine Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET	500	10
53489-676-06	Phentermine Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	10
53489-676-07	Phentermine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30	10
53489-676-10	Phentermine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-676-01	EA - Each	53489-676	dae2d297-9f54-4885-bb4d-db3c0663383e	1	2013-10-17
53489-676-10	EA - Each	53489-676	70d1e3f8-2494-4b6e-ad13-f8382437be48	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
crospovidone	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
povidones	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	6
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
crospovidone	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
povidones	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
crospovidone	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
povidones	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	2
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	2
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
povidones	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-676	PHENTERMINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	9	Current NDC, Legacy NDC, 6 package rows	20200228_02b8f684-b1ca-4ab7-9567-bcacc6a92779.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine HCL C-IV	PHENTERMINE HCL C-IV	Direct_Rx	4cec0e47-5373-2133-e063-6394a90a2009	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	aa9d7161-cda3-4ded-8d5b-424abd1a6681	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	0e893b62-bb07-4984-9f0a-3601435fbc27	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Northwind Health Company, LLC	1b5396a8-e7ef-45ae-e063-6294a90a14a2	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	abf702d6-6f94-48dc-ad23-c52fd74e83a8	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	12699287-9ca9-07b3-e063-6294a90af21a	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	02b8f684-b1ca-4ab7-9567-bcacc6a92779	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526 ndc (product): 53489-676
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	312d9742-6a65-c1cb-e063-6394a90a2e66	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8abf898e-318b-3519-e053-2995a90abf2f	2024-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	53cad049-f1b4-42c0-9cc7-a1c2df75ac58	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	0ca26b58-0a93-4a10-be4d-63a4ad5eecf8	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	ac8559a0-98fe-4737-b9ec-e36eef3b14fc	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	c5d60a6d-2410-4a3c-88e1-a6126b56cf6a	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	95f908c2-1003-4e8f-8e4a-86f493456878	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	83802088-f4fc-4b34-9268-d63fb2ad1655	2023-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	b14a8f6a-a1c6-4104-80f2-0fa35320d04c	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K2I505OTV	PHENTERMINE HYDROCHLORIDE	1197-21-3	PHENTERMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	0e893b62-bb07-4984-9f0a-3601435fbc27	14
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	0e893b62-bb07-4984-9f0a-3601435fbc27	14
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	0e893b62-bb07-4984-9f0a-3601435fbc27	14
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	02b8f684-b1ca-4ab7-9567-bcacc6a92779	10
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	02b8f684-b1ca-4ab7-9567-bcacc6a92779	10
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	02b8f684-b1ca-4ab7-9567-bcacc6a92779	10
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	d1d74574-9ebc-45fc-86e9-8cbd59acacd4	4
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	d1d74574-9ebc-45fc-86e9-8cbd59acacd4	4
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	d1d74574-9ebc-45fc-86e9-8cbd59acacd4	4
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	aa9d7161-cda3-4ded-8d5b-424abd1a6681	2
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	aa9d7161-cda3-4ded-8d5b-424abd1a6681	2
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	aa9d7161-cda3-4ded-8d5b-424abd1a6681	2
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	4cec0e47-5373-2133-e063-6394a90a2009	1
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	4cec0e47-5373-2133-e063-6394a90a2009	1
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	4cec0e47-5373-2133-e063-6394a90a2009	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53489-676-01	53489067601	100 TABLET in 1 BOTTLE, PLASTIC (53489-676-01)	100 tablet	2013-08-12	0000-00-00	No	No	Current
53489-676-03	53489067603	250 TABLET in 1 BOTTLE, PLASTIC (53489-676-03)	250 tablet	2013-08-12	0000-00-00	No	No	Current
53489-676-05	53489067605	500 TABLET in 1 BOTTLE, PLASTIC (53489-676-05)	500 tablet	2013-08-12	0000-00-00	No	No	Current
53489-676-06	53489067606	60 TABLET in 1 BOTTLE, PLASTIC (53489-676-06)	60 tablet	2013-08-12	0000-00-00	No	No	Current
53489-676-07	53489067607	30 TABLET in 1 BOTTLE, PLASTIC (53489-676-07)	30 tablet	2013-08-12	0000-00-00	No	No	Current
53489-676-10	53489067610	1000 TABLET in 1 BOTTLE, PLASTIC (53489-676-10)	1000 tablet	2013-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine HCL C-IV	Direct_Rx	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	1
Phentermine Hydrochloride	Calvin Scott & Co., Inc.	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	2
Phentermine Hydrochloride	A-S Medication Solutions	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	14
Phentermine Hydrochloride	Northwind Pharmaceuticals, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Phentermine Hydrochloride	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	2
Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	24
Phentermine Hydrochloride	Martek Pharmacal Co.	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	3
Phentermine Hydrochloride	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm Inc. \| ALKALOIDA Chemical Company Zrt.	2025-07-14	HUMAN PRESCRIPTION DRUG LABEL	10
Phentermine Hydrochloride	NuCare Pharmaceuticals,Inc.	2025-03-25	HUMAN PRESCRIPTION DRUG LABEL	1
Phentermine Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-09-11	HUMAN PRESCRIPTION DRUG LABEL	5
Phentermine Hydrochloride	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	11
Phentermine Hydrochloride	Bryant Ranch Prepack	2024-06-06	HUMAN PRESCRIPTION DRUG LABEL	5
Phentermine Hydrochloride	Bryant Ranch Prepack	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	7
Phentermine Hydrochloride	Bryant Ranch Prepack	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	6
Phentermine Hydrochloride	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	3
Phentermine Hydrochloride	Bryant Ranch Prepack	2023-09-27	HUMAN PRESCRIPTION DRUG LABEL	103
Phentermine Hydrochloride	Proficient Rx LP	2023-05-01	HUMAN PRESCRIPTION DRUG LABEL	2
Phentermine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Phentermine Hydrochloride	NuCare Pharmaceuticals, Inc.	2022-05-05	HUMAN PRESCRIPTION DRUG LABEL	5
Phentermine Hydrochloride	A-S Medication Solutions	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	7
Phentermine Hydrochloride	Unit Dose Services	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL	4
Phentermine Hydrochloride	Aidarex Pharmaceuticals LLC	2017-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
Phentermine Hydrochloride	Blenheim Pharmacal, Inc.	2015-07-31	HUMAN PRESCRIPTION DRUG LABEL	3