Phentermine Hydrochloride

Product NDC: 12634-516
11-digit product format: 126340516
Labeler code: 12634
Product ID: 12634-516_3648073a-ac05-2c76-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA040875
Marketing category: ANDA
Marketing start: 2012-08-07
Marketing end: 0000-00-00
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
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 · 38 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-516		I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-00	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-01	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-09	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-40	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-42	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-45	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-50	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-52	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-54	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-57	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-58	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-59	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-60	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-61	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-63	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-66	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-67	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-69	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-71	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-74	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-78	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-79	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-80	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-81	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-82	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-84	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-85	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-90	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-91	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-92	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-93	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-94	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-95	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-96	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-97	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-98	I	Inactivated by FDA	2026-08-07
excluded package	package	12634-516	12634-516-99	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 13 · 722 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-516-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-516-95	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A040875-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2008-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040875-001	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	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040875-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-21	`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	A040875-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040875-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040875-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040875-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040875-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040875-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040875-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040875-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040875-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040875-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040875-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040875-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040875-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040875-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040875-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040875-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040875-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040875-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040875-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040875-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040875-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040875-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040875-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040875-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040875-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040875-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040875-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040875-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040875-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040875-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040875-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040875-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040875-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040875-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040875-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040875-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040875-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040875-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040875-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040875-001	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, Related label table
NDC	Related label
12634-516-00	Phentermine HCL 30 mg
12634-516-01	Phentermine HCL 30 mg
12634-516-09	Phentermine HCL 30 mg
12634-516-40	Phentermine HCL 30 mg
12634-516-42	Phentermine HCL 30 mg
12634-516-45	Phentermine HCL 30 mg
12634-516-50	Phentermine HCL 30 mg
12634-516-52	Phentermine HCL 30 mg
12634-516-54	Phentermine HCL 30 mg
12634-516-57	Phentermine HCL 30 mg
12634-516-58	Phentermine HCL 30 mg
12634-516-59	Phentermine HCL 30 mg
12634-516-60	Phentermine HCL 30 mg
12634-516-61	Phentermine HCL 30 mg
12634-516-63	Phentermine HCL 30 mg
12634-516-66	Phentermine HCL 30 mg
12634-516-67	Phentermine HCL 30 mg
12634-516-69	Phentermine HCL 30 mg
12634-516-71	Phentermine HCL 30 mg
12634-516-74	Phentermine HCL 30 mg
12634-516-78	Phentermine HCL 30 mg
12634-516-79	Phentermine HCL 30 mg
12634-516-80	Phentermine HCL 30 mg
12634-516-81	Phentermine HCL 30 mg
12634-516-82	Phentermine HCL 30 mg
12634-516-84	Phentermine HCL 30 mg
12634-516-85	Phentermine HCL 30 mg
12634-516-90	Phentermine HCL 30 mg
12634-516-91	Phentermine HCL 30 mg
12634-516-92	Phentermine HCL 30 mg
12634-516-93	Phentermine HCL 30 mg
12634-516-94	Phentermine HCL 30 mg
12634-516-95	Phentermine HCL 30 mg
12634-516-96	Phentermine HCL 30 mg
12634-516-97	Phentermine HCL 30 mg
12634-516-98	Phentermine HCL 30 mg
12634-516-99	Phentermine HCL 30 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-516-00	Phentermine Hydrochloride	10 in 1 BOTTLE	CAPSULE	10	3
12634-516-01	Phentermine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	3
12634-516-09	Phentermine Hydrochloride	35 in 1 BOTTLE	CAPSULE	35	3
12634-516-40	Phentermine Hydrochloride	40 in 1 BOTTLE	CAPSULE	40	3
12634-516-42	Phentermine Hydrochloride	42 in 1 BOTTLE	CAPSULE	42	3
12634-516-45	Phentermine Hydrochloride	45 in 1 BOTTLE	CAPSULE	45	3
12634-516-50	Phentermine Hydrochloride	50 in 1 BOTTLE	CAPSULE	50	3
12634-516-52	Phentermine Hydrochloride	12 in 1 BLISTER PACK	CAPSULE	12	3
12634-516-54	Phentermine Hydrochloride	14 in 1 BLISTER PACK	CAPSULE	14	3
12634-516-57	Phentermine Hydrochloride	20 in 1 BLISTER PACK	CAPSULE	20	3
12634-516-58	Phentermine Hydrochloride	28 in 1 BLISTER PACK	CAPSULE	28	3
12634-516-59	Phentermine Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30	3
12634-516-60	Phentermine Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	3
12634-516-61	Phentermine Hydrochloride	10 in 1 BLISTER PACK	CAPSULE	10	3
12634-516-63	Phentermine Hydrochloride	3 in 1 BLISTER PACK	CAPSULE	3	3
12634-516-66	Phentermine Hydrochloride	6 in 1 BLISTER PACK	CAPSULE	6	3
12634-516-67	Phentermine Hydrochloride	7 in 1 BLISTER PACK	CAPSULE	7	3
12634-516-69	Phentermine Hydrochloride	9 in 1 BLISTER PACK	CAPSULE	9	3
12634-516-71	Phentermine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	3
12634-516-74	Phentermine Hydrochloride	24 in 1 BOTTLE	CAPSULE	24	3
12634-516-78	Phentermine Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	3
12634-516-79	Phentermine Hydrochloride	25 in 1 BOTTLE	CAPSULE	25	3
12634-516-80	Phentermine Hydrochloride	20 in 1 BOTTLE	CAPSULE	20	3
12634-516-81	Phentermine Hydrochloride	21 in 1 BOTTLE	CAPSULE	21	3
12634-516-82	Phentermine Hydrochloride	12 in 1 BOTTLE	CAPSULE	12	3
12634-516-84	Phentermine Hydrochloride	14 in 1 BOTTLE	CAPSULE	14	3
12634-516-85	Phentermine Hydrochloride	15 in 1 BOTTLE	CAPSULE	15	3
12634-516-90	Phentermine Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	3
12634-516-91	Phentermine Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1	3
12634-516-92	Phentermine Hydrochloride	2 in 1 BOTTLE	CAPSULE	2	3
12634-516-93	Phentermine Hydrochloride	3 in 1 BOTTLE	CAPSULE	3	3
12634-516-94	Phentermine Hydrochloride	4 in 1 BOTTLE	CAPSULE	4	3
12634-516-95	Phentermine Hydrochloride	5 in 1 BOTTLE	CAPSULE	5	3
12634-516-96	Phentermine Hydrochloride	6 in 1 BOTTLE	CAPSULE	6	3
12634-516-97	Phentermine Hydrochloride	7 in 1 BOTTLE	CAPSULE	7	3
12634-516-98	Phentermine Hydrochloride	8 in 1 BOTTLE	CAPSULE	8	3
12634-516-99	Phentermine Hydrochloride	9 in 1 BOTTLE	CAPSULE	9	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-516	PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA INC.]	3	Legacy NDC, 37 package rows	20160629_d8ddc6a0-29d0-4730-b718-1bdb2937a91c.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6749c074-52a1-4d74-96a2-d9302b3c49a1	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	5234cabd-6b3e-404d-a0cd-256ee5fcc8f1	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	7198d596-3e1c-49d5-91aa-c62fa2e2b800	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	7f1c3a5d-dd9b-4441-a483-aa5777f8e40c	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-Tech, Inc.	b963f7bb-fa65-4e28-81c9-282fbe70a6a6	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f938b0ab-606e-8b21-e053-6294a90a4f4c	2023-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	f2da0b5a-c7d6-48c3-98e9-7c611eb6ff7e	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040875 application number: ANDA040875

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	d8ddc6a0-29d0-4730-b718-1bdb2937a91c	3
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	d8ddc6a0-29d0-4730-b718-1bdb2937a91c	3
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	d8ddc6a0-29d0-4730-b718-1bdb2937a91c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-516-00	12634051600	10 in 1 BOTTLE	Historical
12634-516-01	12634051601	100 in 1 BOTTLE	Historical
12634-516-09	12634051609	35 in 1 BOTTLE	Historical
12634-516-40	12634051640	40 in 1 BOTTLE	Historical
12634-516-42	12634051642	42 in 1 BOTTLE	Historical
12634-516-45	12634051645	45 in 1 BOTTLE	Historical
12634-516-50	12634051650	50 in 1 BOTTLE	Historical
12634-516-52	12634051652	12 in 1 BLISTER PACK	Historical
12634-516-54	12634051654	14 in 1 BLISTER PACK	Historical
12634-516-57	12634051657	20 in 1 BLISTER PACK	Historical
12634-516-58	12634051658	28 in 1 BLISTER PACK	Historical
12634-516-59	12634051659	30 in 1 BLISTER PACK	Historical
12634-516-60	12634051660	60 in 1 BOTTLE	Historical
12634-516-61	12634051661	10 in 1 BLISTER PACK	Historical
12634-516-63	12634051663	3 in 1 BLISTER PACK	Historical
12634-516-66	12634051666	6 in 1 BLISTER PACK	Historical
12634-516-67	12634051667	7 in 1 BLISTER PACK	Historical
12634-516-69	12634051669	9 in 1 BLISTER PACK	Historical
12634-516-71	12634051671	30 in 1 BOTTLE	Historical
12634-516-74	12634051674	24 in 1 BOTTLE	Historical
12634-516-78	12634051678	28 in 1 BOTTLE	Historical
12634-516-79	12634051679	25 in 1 BOTTLE	Historical
12634-516-80	12634051680	20 in 1 BOTTLE	Historical
12634-516-81	12634051681	21 in 1 BOTTLE	Historical
12634-516-82	12634051682	12 in 1 BOTTLE	Historical
12634-516-84	12634051684	14 in 1 BOTTLE	Historical
12634-516-85	12634051685	15 in 1 BOTTLE	Historical
12634-516-90	12634051690	90 in 1 BOTTLE	Historical
12634-516-91	12634051691	1 in 1 BLISTER PACK	Historical
12634-516-92	12634051692	2 in 1 BOTTLE	Historical
12634-516-93	12634051693	3 in 1 BOTTLE	Historical
12634-516-94	12634051694	4 in 1 BOTTLE	Historical
12634-516-95	12634051695	5 in 1 BOTTLE	Historical
12634-516-96	12634051696	6 in 1 BOTTLE	Historical
12634-516-97	12634051697	7 in 1 BOTTLE	Historical
12634-516-98	12634051698	8 in 1 BOTTLE	Historical
12634-516-99	12634051699	9 in 1 BOTTLE	Historical