Phentermine Hydrochloride

Product NDC: 61939-810
11-digit product format: 619390810
Labeler code: 61939
Product ID: 61939-810_ddf2a781-8150-4452-97df-a41ff3caeff3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Mikah Pharma, LLC
Application: ANDA040190
Marketing category: ANDA
Marketing start: 2014-05-01
Marketing end: 0000-00-00
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 38 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: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61939-810		I	Inactivated by FDA	2026-08-07
excluded package	package	61939-810	61939-810-01	I	Inactivated by FDA	2026-08-07
excluded package	package	61939-810	61939-810-10	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 2 · 63 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	61939-810-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61939-810-01	`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	61939-810-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61939-810-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61939-810-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61939-810-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61939-810-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61939-810-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61939-810-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61939-810-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61939-810-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61939-810-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61939-810-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61939-810-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61939-810-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61939-810-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61939-810-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61939-810-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61939-810-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61939-810-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61939-810-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61939-810-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61939-810-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61939-810-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61939-810-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61939-810-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61939-810-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61939-810-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61939-810-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61939-810-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61939-810-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61939-810-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61939-810-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61939-810-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61939-810-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61939-810-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61939-810-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61939-810-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61939-810-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61939-810-01	`e2bbac7714bc…`	`27bdfed8d636…`

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
A040190-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		1997-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040190-001	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	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`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	A040190-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040190-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040190-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040190-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040190-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040190-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040190-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040190-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040190-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040190-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040190-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040190-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040190-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040190-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040190-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040190-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040190-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040190-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040190-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040190-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040190-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040190-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040190-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040190-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040190-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040190-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040190-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040190-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040190-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040190-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040190-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040190-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040190-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040190-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040190-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040190-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040190-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040190-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040190-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040190-001	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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61939-810-01	2020-01-31	C162847	48780-1	9d75b9d0-b272-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use [Phentermine Hydrochloride Tablets, USP] safely and effectively. See full prescribing information for [Phentermine Hydrochloride Tablets, USP CIV for oral use ]. Initial U.S. Approval: [1959]
61939-810-10	2020-01-31	C162847	48780-1	9d75b9d0-b272-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use [Phentermine Hydrochloride Tablets, USP] safely and effectively. See full prescribing information for [Phentermine Hydrochloride Tablets, USP CIV for oral use ]. Initial U.S. Approval: [1959]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61939-810-01	Phentermine Hydrochloride	100 in 1 BOTTLE	TABLET	100		2
61939-810-10	Phentermine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61939-810	PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]	2	Legacy NDC, 2 package rows	20150227_ddf2a781-8150-4452-97df-a41ff3caeff3.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 · 2 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.	eae1d7f9-733c-434b-9199-5f7052e541da	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040190 application number: ANDA040190
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Elite Laboratories, Inc.	0b7ad9c0-9e1e-4a69-802b-28f44267e34d	2017-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040190 application number: ANDA040190

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
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	ddf2a781-8150-4452-97df-a41ff3caeff3	2
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	ddf2a781-8150-4452-97df-a41ff3caeff3	2
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	ddf2a781-8150-4452-97df-a41ff3caeff3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61939-810-01	61939081001	100 in 1 BOTTLE	Historical
61939-810-10	61939081010	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	Mikah Pharma, LLC \| Elite Laboratories, Inc.	2015-02-26	HUMAN PRESCRIPTION DRUG LABEL	2