Phentermine Hydrochloride

Product NDC: 84053-910
Requested package NDC: 84053-910-07
11-digit product format: 840530910
Labeler code: 84053
Product ID: 84053-910_48fd28f6-101b-498c-e063-6294a90aba52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Martek Pharmacal Co.
Application: ANDA202248
Marketing category: ANDA
Marketing start: 2024-02-12
Marketing end: 2028-04-29
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
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202248-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2012-09-28
A202248-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202248-001	AA
A202248-002	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 3 · 82 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	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A202248-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202248-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202248-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202248-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202248-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202248-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202248-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202248-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202248-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202248-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202248-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202248-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202248-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202248-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202248-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202248-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202248-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202248-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phentermine Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	30 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
900038	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
1149f69d-65df-6a98-e063-6394a90aeaa4	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
84053-910-07	Phentermine Hydrochloride	7 in 1 BOTTLE	CAPSULE	7	8
84053-910-14	Phentermine Hydrochloride	14 in 1 BOTTLE	CAPSULE	14	8
84053-910-21	Phentermine Hydrochloride	21 in 1 BOTTLE	CAPSULE	21	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84053-910	PHENTERMINE HYDROCHLORIDE CAPSULE [MARTEK PHARMACAL CO.]	6	Current NDC, 3 package rows	20240718_1149f69d-65df-6a98-e063-6394a90aeaa4.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b425840f-380e-42bd-852a-6ee3641977ce	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e48feec6-50c9-4ccd-b9da-56956d14c853	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1149f69d-65df-6a98-e063-6394a90aeaa4	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248 ndc (package): 84053-910-07 ndc (product): 84053-910 ndc11 (package): 84053091007
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d76940d3-95e6-442d-99ef-4fe92de7a376	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Precision Dose Inc.	095a2be5-721e-46e6-976f-9137c855cd22	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	723c37c4-868f-40f0-b74d-137dcbb93f9f	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	8c7c1391-bfd1-48f9-b249-9729fe648b89	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248

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
900038	phentermine HCl 30 MG Oral Capsule	PSN	1149f69d-65df-6a98-e063-6394a90aeaa4	8
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	1149f69d-65df-6a98-e063-6394a90aeaa4	8
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	1149f69d-65df-6a98-e063-6394a90aeaa4	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
84053-910-07	84053091007	7 CAPSULE in 1 BOTTLE (84053-910-07)	7 capsule	2026-01-22	2028-04-29	No	No	Historical