PHENTERMINE HYDROCHLORIDE

Product NDC: 61919-557
Requested package NDC: 61919-557-30
11-digit product format: 619190557
Labeler code: 61919
Product ID: 61919-557_8d4168dd-59fb-188d-e053-2995a90aab43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENTERMINE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA087022
Marketing category: ANDA
Marketing start: 2019-07-09
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-557	61919-557-30	I	Inactivated by FDA		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A087022-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1983-02-03
A087022-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL			2012-01-20

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	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087022-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087022-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087022-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087022-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087022-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087022-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087022-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087022-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087022-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087022-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087022-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087022-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087022-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087022-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087022-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087022-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087022-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A087022-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087022-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A087022-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087022-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A087022-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087022-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A087022-002	AA	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A087022-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A087022-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087022-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087022-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087022-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A087022-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087022-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A087022-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087022-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087022-002	AA	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-557-30	2023-01-30	C162847	48780-1	f386c64a-2c29-0266-e053-dadaa90a7c1a	PHENTERMINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-557-30	PHENTERMINE HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-557-30	EA - Each	61919-557	63970052-cc07-43ca-b884-f30341488770	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-557	PHENTERMINE HYDROCHLORIDE CAPSULE [DIRECT_RX]	1	Legacy NDC, 1 package rows	20190802_8d4168dd-59fa-188d-e053-2995a90aab43.zip

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
968766	phentermine HCl 15 MG Oral Capsule	PSN	8d4168dd-59fa-188d-e053-2995a90aab43	1
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	8d4168dd-59fa-188d-e053-2995a90aab43	1
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	8d4168dd-59fa-188d-e053-2995a90aab43	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-557-30	61919055730	30 CAPSULE in 1 BOTTLE (61919-557-30)	30 capsule	2019-07-09	0000-00-00	No	No	Current