Phentermine Hydrochloride

Product NDC: 71335-0419
11-digit product format: 713350419
Labeler code: 71335
Product ID: 71335-0419_e78f3cac-9ced-4e78-8ce4-17ddfe54e25a
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
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0419		D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-0	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-1	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-2	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-3	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-4	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-5	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-6	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-7	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-8	D	Discontinued by firm	2026-08-10
excluded package	package	71335-0419	71335-0419-9	D	Discontinued by firm	2026-08-10

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0419-1	EA - Each	71335-0419	0f66f9f0-c41e-4da0-9b55-f8ef34d58754	1	2018-02-20
71335-0419-2	EA - Each	71335-0419	50469ba4-8691-4e23-a91f-8eaa54a5d060	1	2018-02-20
71335-0419-3	EA - Each	71335-0419	759a6961-344c-4484-a7ee-f120943a19a6	1	2018-02-20
71335-0419-4	EA - Each	71335-0419	9bd0bae2-c9cb-42a8-967b-af6ef729f953	1	2018-02-20
71335-0419-5	EA - Each	71335-0419	b596eb3f-ff8f-49fe-b504-7ea77b8313a1	1	2018-02-20
71335-0419-6	EA - Each	71335-0419	9330f00a-fd7a-4709-bf45-1376ed835613	1	2018-02-20
71335-0419-7	EA - Each	71335-0419	37edcb79-c44f-42a5-a9e2-ab23ca2f919d	1	2018-02-20
71335-0419-8	EA - Each	71335-0419	e53e4801-5933-4028-b50e-d5e0a558a5ea	1	2018-02-20
71335-0419-9	EA - Each	71335-0419	4c4a1b46-522f-4033-9c09-9daca11724f4	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0419	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	13	Legacy NDC	20240821_ceddcff6-b844-4285-acd5-198696c2e355.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0419-0	71335041900	45 CAPSULE in 1 BOTTLE (71335-0419-0)	45 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-1	71335041901	7 CAPSULE in 1 BOTTLE (71335-0419-1)	7 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-2	71335041902	14 CAPSULE in 1 BOTTLE (71335-0419-2)	14 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-3	71335041903	30 CAPSULE in 1 BOTTLE (71335-0419-3)	30 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-4	71335041904	100 CAPSULE in 1 BOTTLE (71335-0419-4)	100 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-5	71335041905	2 CAPSULE in 1 BOTTLE (71335-0419-5)	2 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-6	71335041906	28 CAPSULE in 1 BOTTLE (71335-0419-6)	28 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-7	71335041907	90 CAPSULE in 1 BOTTLE (71335-0419-7)	90 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-8	71335041908	21 CAPSULE in 1 BOTTLE (71335-0419-8)	21 capsule	2014-10-16	0000-00-00	No	No	Current
71335-0419-9	71335041909	60 CAPSULE in 1 BOTTLE (71335-0419-9)	60 capsule	2014-10-16	0000-00-00	No	No	Current