Phentermine Hydrochloride

Product NDC: 12634-552
11-digit product format: 126340552
Labeler code: 12634
Product ID: 12634-552_36d2ea29-459a-6ac9-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA040886
Marketing category: ANDA
Marketing start: 2012-08-07
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 · 44 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-552		I	Inactivated by FDA	2026-08-07
excluded product	product	12634-552		D	Discontinued by firm	2026-08-07
excluded package	package	12634-552	12634-552-00	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-01	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-09	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-40	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-42	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-45	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-50	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-52	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-54	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-57	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-58	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-59	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-60	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-61	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-63	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-66	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-67	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-69	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-71	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-74	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-78	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-79	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-80	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-81	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-82	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-84	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-85	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-90	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-91	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-92	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-93	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-94	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-95	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-96	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-97	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-98	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-99	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-552	12634-552-71	D	Discontinued by firm	2026-08-07
excluded package	package	12634-552	12634-552-78	D	Discontinued by firm	2026-08-07
excluded package	package	12634-552	12634-552-84	D	Discontinued by firm	2026-08-07
excluded package	package	12634-552	12634-552-91	D	Discontinued by firm	2026-08-07
excluded package	package	12634-552	12634-552-97	D	Discontinued by firm	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 14 · 794 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-97	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-61	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-59	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-52	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-74	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-63	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-78	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-78	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-81	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-50	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-71	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-57	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-84	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-66	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-91	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-95	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-80	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-84	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-71	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-98	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-93	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-69	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-42	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-94	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-85	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-40	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-91	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-67	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-45	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-58	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-09	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-97	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-82	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-79	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-92	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-54	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-96	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-99	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-552-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-97	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-61	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-59	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-52	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-74	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-63	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-78	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-78	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-81	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-50	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-71	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-57	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-84	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-552-66	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A040886-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2008-03-31
A040886-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040886-001	AA
A040886-002	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	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`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	A040886-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040886-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040886-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040886-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040886-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040886-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040886-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040886-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040886-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040886-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040886-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040886-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040886-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040886-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040886-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040886-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040886-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040886-002	AA	1	`782e0a99824c…`

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, Related label table
NDC	Related label
12634-552-00	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-01	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-09	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-40	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-42	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-45	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-50	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-52	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-54	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-57	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-58	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-59	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-60	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-61	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-63	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-66	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-67	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-69	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-71	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-74	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-78	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-79	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-80	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-81	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-82	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-84	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-85	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-90	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-91	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-92	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-93	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-94	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-95	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-96	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-97	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-98	36d2ea29-4599-6ac9-e054-00144ff88e88
12634-552-99	36d2ea29-4599-6ac9-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-552-00	Phentermine Hydrochloride	10 in 1 BOTTLE	CAPSULE	10	2
12634-552-01	Phentermine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	2
12634-552-09	Phentermine Hydrochloride	35 in 1 BOTTLE	CAPSULE	35	2
12634-552-40	Phentermine Hydrochloride	40 in 1 BOTTLE	CAPSULE	40	2
12634-552-42	Phentermine Hydrochloride	42 in 1 BOTTLE	CAPSULE	42	2
12634-552-45	Phentermine Hydrochloride	45 in 1 BOTTLE	CAPSULE	45	2
12634-552-50	Phentermine Hydrochloride	50 in 1 BOTTLE	CAPSULE	50	2
12634-552-52	Phentermine Hydrochloride	12 in 1 BLISTER PACK	CAPSULE	12	2
12634-552-54	Phentermine Hydrochloride	14 in 1 BLISTER PACK	CAPSULE	14	2
12634-552-57	Phentermine Hydrochloride	20 in 1 BLISTER PACK	CAPSULE	20	2
12634-552-58	Phentermine Hydrochloride	28 in 1 BLISTER PACK	CAPSULE	28	2
12634-552-59	Phentermine Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30	2
12634-552-60	Phentermine Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	2
12634-552-61	Phentermine Hydrochloride	10 in 1 BLISTER PACK	CAPSULE	10	2
12634-552-63	Phentermine Hydrochloride	3 in 1 BLISTER PACK	CAPSULE	3	2
12634-552-66	Phentermine Hydrochloride	6 in 1 BLISTER PACK	CAPSULE	6	2
12634-552-67	Phentermine Hydrochloride	7 in 1 BLISTER PACK	CAPSULE	7	2
12634-552-69	Phentermine Hydrochloride	9 in 1 BLISTER PACK	CAPSULE	9	2
12634-552-71	Phentermine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	2
12634-552-74	Phentermine Hydrochloride	24 in 1 BOTTLE	CAPSULE	24	2
12634-552-78	Phentermine Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	2
12634-552-79	Phentermine Hydrochloride	25 in 1 BOTTLE	CAPSULE	25	2
12634-552-80	Phentermine Hydrochloride	20 in 1 BOTTLE	CAPSULE	20	2
12634-552-81	Phentermine Hydrochloride	21 in 1 BOTTLE	CAPSULE	21	2
12634-552-82	Phentermine Hydrochloride	12 in 1 BOTTLE	CAPSULE	12	2
12634-552-84	Phentermine Hydrochloride	14 in 1 BOTTLE	CAPSULE	14	2
12634-552-85	Phentermine Hydrochloride	15 in 1 BOTTLE	CAPSULE	15	2
12634-552-90	Phentermine Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	2
12634-552-91	Phentermine Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1	2
12634-552-92	Phentermine Hydrochloride	2 in 1 BOTTLE	CAPSULE	2	2
12634-552-93	Phentermine Hydrochloride	3 in 1 BOTTLE	CAPSULE	3	2
12634-552-94	Phentermine Hydrochloride	4 in 1 BOTTLE	CAPSULE	4	2
12634-552-95	Phentermine Hydrochloride	5 in 1 BOTTLE	CAPSULE	5	2
12634-552-96	Phentermine Hydrochloride	6 in 1 BOTTLE	CAPSULE	6	2
12634-552-97	Phentermine Hydrochloride	7 in 1 BOTTLE	CAPSULE	7	2
12634-552-98	Phentermine Hydrochloride	8 in 1 BOTTLE	CAPSULE	8	2
12634-552-99	Phentermine Hydrochloride	9 in 1 BOTTLE	CAPSULE	9	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-552	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA INC.]	2	Legacy NDC, 37 package rows	20160706_36d2ea29-4599-6ac9-e054-00144ff88e88.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	2f3b738f-d66b-40c1-8e69-bcd50bce3e47	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4000c00f-aa6c-4ea5-af0e-149dde3c74db	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f115ad6d-cf62-40e7-89d1-6183a9b5071f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2abc445c-daa8-7326-e054-00144ff88e88	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	5234cabd-6b3e-404d-a0cd-256ee5fcc8f1	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1fe86035-19ef-4944-ad81-c0167a8e7fec	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0b4d847a-fcda-df31-e063-6294a90a0c5e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	7f1c3a5d-dd9b-4441-a483-aa5777f8e40c	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-Tech, Inc.	b963f7bb-fa65-4e28-81c9-282fbe70a6a6	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	3a3259ec-ded3-427f-843d-928d130de3da	2020-03-01	Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886

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	36d2ea29-4599-6ac9-e054-00144ff88e88	2
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	36d2ea29-4599-6ac9-e054-00144ff88e88	2
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	36d2ea29-4599-6ac9-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-552-00	12634055200	10 in 1 BOTTLE	Historical
12634-552-01	12634055201	100 in 1 BOTTLE	Historical
12634-552-09	12634055209	35 in 1 BOTTLE	Historical
12634-552-40	12634055240	40 in 1 BOTTLE	Historical
12634-552-42	12634055242	42 in 1 BOTTLE	Historical
12634-552-45	12634055245	45 in 1 BOTTLE	Historical
12634-552-50	12634055250	50 in 1 BOTTLE	Historical
12634-552-52	12634055252	12 in 1 BLISTER PACK	Historical
12634-552-54	12634055254	14 in 1 BLISTER PACK	Historical
12634-552-57	12634055257	20 in 1 BLISTER PACK	Historical
12634-552-58	12634055258	28 in 1 BLISTER PACK	Historical
12634-552-59	12634055259	30 in 1 BLISTER PACK	Historical
12634-552-60	12634055260	60 in 1 BOTTLE	Historical
12634-552-61	12634055261	10 in 1 BLISTER PACK	Historical
12634-552-63	12634055263	3 in 1 BLISTER PACK	Historical
12634-552-66	12634055266	6 in 1 BLISTER PACK	Historical
12634-552-67	12634055267	7 in 1 BLISTER PACK	Historical
12634-552-69	12634055269	9 in 1 BLISTER PACK	Historical
12634-552-71	12634055271	30 in 1 BOTTLE	Historical
12634-552-74	12634055274	24 in 1 BOTTLE	Historical
12634-552-78	12634055278	28 in 1 BOTTLE	Historical
12634-552-79	12634055279	25 in 1 BOTTLE	Historical
12634-552-80	12634055280	20 in 1 BOTTLE	Historical
12634-552-81	12634055281	21 in 1 BOTTLE	Historical
12634-552-82	12634055282	12 in 1 BOTTLE	Historical
12634-552-84	12634055284	14 in 1 BOTTLE	Historical
12634-552-85	12634055285	15 in 1 BOTTLE	Historical
12634-552-90	12634055290	90 in 1 BOTTLE	Historical
12634-552-91	12634055291	1 in 1 BLISTER PACK	Historical
12634-552-92	12634055292	2 in 1 BOTTLE	Historical
12634-552-93	12634055293	3 in 1 BOTTLE	Historical
12634-552-94	12634055294	4 in 1 BOTTLE	Historical
12634-552-95	12634055295	5 in 1 BOTTLE	Historical
12634-552-96	12634055296	6 in 1 BOTTLE	Historical
12634-552-97	12634055297	7 in 1 BOTTLE	Historical
12634-552-98	12634055298	8 in 1 BOTTLE	Historical
12634-552-99	12634055299	9 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride - Apotheca Inc.	Apotheca Inc.	2016-07-04	HUMAN PRESCRIPTION DRUG LABEL	2