MIPLYFFA

Product NDC: 72542-162
11-digit product format: 725420162
Labeler code: 72542
Product ID: 72542-162_18850625-1a1d-4351-862e-5d46b08eb978
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: arimoclomol citrate
Dosage form: CAPSULE
Route: ORAL
Labeler: Acer Therapeutics Inc.
Application: NDA214927
Marketing category: NDA
Marketing start: 2024-09-20
Substance: ARIMOCLOMOL CITRATE
Active strength: 62 mg/1
Pharmacologic classes: Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214927-001	MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20
N214927-002	MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20
N214927-003	MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20
N214927-004	MIPLYFFA	ARIMOCLOMOL CITRATE	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214927-001	9884058	2029-06-26	U-4021		2024-10-21
N214927-001	9289472	2029-08-11	U-4021		2024-10-21
N214927-001	11045460	2029-08-19	U-4021		2024-10-21
N214927-001	11707456	2041-11-19	U-4021	Drug substance, Drug product	2026-06-05
N214927-002	9884058	2029-06-26	U-4021		2024-10-21
N214927-002	9289472	2029-08-11	U-4021		2024-10-21
N214927-002	11045460	2029-08-19	U-4021		2024-10-21
N214927-002	11707456	2041-11-19	U-4021	Drug substance, Drug product	2026-06-05
N214927-003	9884058	2029-06-26	U-4021		2024-10-21
N214927-003	9289472	2029-08-11	U-4021		2024-10-21
N214927-003	11045460	2029-08-19	U-4021		2024-10-21
N214927-003	11707456	2041-11-19	U-4021	Drug substance, Drug product	2026-06-05
N214927-004	9884058	2029-06-26	U-4021		2024-10-21
N214927-004	9289472	2029-08-11	U-4021		2024-10-21
N214927-004	11045460	2029-08-19	U-4021		2024-10-21
N214927-004	11707456	2041-11-19	U-4021	Drug substance, Drug product	2026-06-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214927-001	NCE	2029-09-20
N214927-001	ODE-496	2031-09-20
N214927-002	NCE	2029-09-20
N214927-002	ODE-496	2031-09-20
N214927-003	NCE	2029-09-20
N214927-003	ODE-496	2031-09-20
N214927-004	NCE	2029-09-20
N214927-004	ODE-496	2031-09-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214927-001	MIPLYFFA	EQ 47MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214927-002	MIPLYFFA	EQ 62MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214927-003	MIPLYFFA	EQ 93MG BASE	CAPSULE / ORAL	RLD	2024-09-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214927-004	MIPLYFFA	EQ 124MG BASE	CAPSULE / ORAL	RLD, RS	2024-09-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214927-001	9884058	2029-06-26	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-001	9289472	2029-08-11	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-001	11045460	2029-08-19	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-002	9884058	2029-06-26	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-002	9289472	2029-08-11	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-002	11045460	2029-08-19	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-003	9884058	2029-06-26	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-003	9289472	2029-08-11	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-003	11045460	2029-08-19	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-004	9884058	2029-06-26	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-004	9289472	2029-08-11	U-4021	2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-004	11045460	2029-08-19	U-4021	2024-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-001	9884058	2029-06-26	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-001	9289472	2029-08-11	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-001	11045460	2029-08-19	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-002	9884058	2029-06-26	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-002	9289472	2029-08-11	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-002	11045460	2029-08-19	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-003	9884058	2029-06-26	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-003	9289472	2029-08-11	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-003	11045460	2029-08-19	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-004	9884058	2029-06-26	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-004	9289472	2029-08-11	U-4021	2024-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-004	11045460	2029-08-19	U-4021	2024-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214927-001	9884058	2029-06-26	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-001	9289472	2029-08-11	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-001	11045460	2029-08-19	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-002	9884058	2029-06-26	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-002	9289472	2029-08-11	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-002	11045460	2029-08-19	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-003	9884058	2029-06-26	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-003	9289472	2029-08-11	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-003	11045460	2029-08-19	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-004	9884058	2029-06-26	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-004	9289472	2029-08-11	U-4021	2024-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-004	11045460	2029-08-19	U-4021	2024-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-001	9884058	2029-06-26	U-4021	2024-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-001	9289472	2029-08-11	U-4021	2024-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-001	11045460	2029-08-19	U-4021	2024-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-002	9884058	2029-06-26	U-4021	2024-10-21	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214927-001	NCE	2029-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-001	ODE-496	2031-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-002	NCE	2029-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-002	ODE-496	2031-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-003	NCE	2029-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-003	ODE-496	2031-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-004	NCE	2029-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214927-004	ODE-496	2031-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-001	NCE	2029-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-001	ODE-496	2031-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-002	NCE	2029-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-002	ODE-496	2031-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-003	NCE	2029-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-003	ODE-496	2031-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-004	NCE	2029-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214927-004	ODE-496	2031-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214927-001	NCE	2029-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-001	ODE-496	2031-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-002	NCE	2029-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-002	ODE-496	2031-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-003	NCE	2029-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-003	ODE-496	2031-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-004	NCE	2029-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214927-004	ODE-496	2031-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-001	NCE	2029-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-001	ODE-496	2031-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-002	NCE	2029-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-002	ODE-496	2031-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-003	NCE	2029-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-003	ODE-496	2031-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-004	NCE	2029-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214927-004	ODE-496	2031-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-001	NCE	2029-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-001	ODE-496	2031-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-002	NCE	2029-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-002	ODE-496	2031-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-003	NCE	2029-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-003	ODE-496	2031-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-004	NCE	2029-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214927-004	ODE-496	2031-09-20	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: MIPLYFFA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIMOCLOMOL CITRATE	62 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q85FFY6179	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2694288	Internal RxNorm lookup
2694294	Internal RxNorm lookup
2694296	Internal RxNorm lookup
2694298	Internal RxNorm lookup
2694300	Internal RxNorm lookup
2694302	Internal RxNorm lookup
2694304	Internal RxNorm lookup
2694306	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5feffc0e-453d-47fa-91dd-38d4952309bc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee65f1ab-b196-42a5-b39d-16b01af4c0de	Product name	1	20250401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72542-162-01	MIPLYFFA	1 in 1 CARTON	CAPSULE	1		5
72542-162-01	MIPLYFFA	90 in 1 BOTTLE	CAPSULE	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72542-162-01	EA - Each	72542-162	1ec7d746-dfa2-47b8-8092-cf54ae3aa49f	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72542-162	MIPLYFFA (ARIMOCLOMOL CITRATE) CAPSULE [ACER THERAPEUTICS INC.]	4	Current NDC, 2 package rows	20241004_5feffc0e-453d-47fa-91dd-38d4952309bc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIPLYFFA	ARIMOCLOMOL CITRATE	Acer Therapeutics Inc.	5feffc0e-453d-47fa-91dd-38d4952309bc	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214927 application number: NDA214927 ndc (product): 72542-162

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q85FFY6179	ARIMOCLOMOL CITRATE	368860-21-3	ARIMOCLOMOL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2694288	arimoclomol 124 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694296	arimoclomol 47 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694300	arimoclomol 62 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694304	arimoclomol 93 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694294	MIPLYFFA 124 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694298	MIPLYFFA 47 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694302	MIPLYFFA 62 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694306	MIPLYFFA 93 MG Oral Capsule	PSN	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694294	arimoclomol 124 MG Oral Capsule [Miplyffa]	SBD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694298	arimoclomol 47 MG Oral Capsule [Miplyffa]	SBD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694302	arimoclomol 62 MG Oral Capsule [Miplyffa]	SBD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694306	arimoclomol 93 MG Oral Capsule [Miplyffa]	SBD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694288	arimoclomol 124 MG Oral Capsule	SCD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694296	arimoclomol 47 MG Oral Capsule	SCD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694300	arimoclomol 62 MG Oral Capsule	SCD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694304	arimoclomol 93 MG Oral Capsule	SCD	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694288	arimoclomol 124 MG (equivalent to 200 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694296	arimoclomol 47 MG (equivalent to 75 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694300	arimoclomol 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694304	arimoclomol 93 MG (equivalent to 150 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694294	Miplyffa 124 MG (equivalent to 200 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694298	Miplyffa 47 MG (equivalent to 75 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694302	Miplyffa 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5
2694306	Miplyffa 93 MG (equivalent to 150 MG arimoclomol citrate) Oral Capsule	SY	5feffc0e-453d-47fa-91dd-38d4952309bc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72542-162-01	72542016201	1 BOTTLE in 1 CARTON (72542-162-01) / 90 CAPSULE in 1 BOTTLE	1 bottle	2024-09-20	No	No	Current