Pregabalin Extended Release

Product NDC: 50228-464
11-digit product format: 502280464
Labeler code: 50228
Product ID: 50228-464_e90bfe09-9adb-03c0-e053-2a95a90a061e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ScieGen Pharmaceuticals, INC.
Application: ANDA215675
Marketing category: ANDA
Marketing start: 2022-09-14
Substance: PREGABALIN
Active strength: 330 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A215675-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14
A215675-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14
A215675-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215675-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215675-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215675-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-09-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A215675-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215675-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215675-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215675-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215675-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215675-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215675-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215675-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215675-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215675-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215675-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215675-003	AB	1	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pregabalin Extended Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	330 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55JG375S6M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1988974	Internal RxNorm lookup
1988977	Internal RxNorm lookup
1988980	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
1544a657-353c-47f8-96ac-a63fa78373f0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
441d8579-bd15-4585-93f4-9de3db2d851d	Product name	4	20251114
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
004d1029-ec13-fc89-74f4-3907cf5b6602	Product name	2	20140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50228-464-05	Pregabalin Extended Release	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500		1
50228-464-30	Pregabalin Extended Release	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-464	PREGABALIN EXTENDED RELEASE (PREGABALIN) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20220920_1544a657-353c-47f8-96ac-a63fa78373f0.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
Pregabalin Extended Release	PREGABALIN	ScieGen Pharmaceuticals, INC.	1544a657-353c-47f8-96ac-a63fa78373f0	2022-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215675 application number: ANDA215675 ndc (product): 50228-464

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
55JG375S6M	PREGABALIN	148553-50-8	PREGABALIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1988974	pregabalin 165 MG 24HR Extended Release Oral Tablet	PSN	1544a657-353c-47f8-96ac-a63fa78373f0	1
1988977	pregabalin 330 MG 24HR Extended Release Oral Tablet	PSN	1544a657-353c-47f8-96ac-a63fa78373f0	1
1988980	pregabalin 82.5 MG 24HR Extended Release Oral Tablet	PSN	1544a657-353c-47f8-96ac-a63fa78373f0	1
1988974	24 HR pregabalin 165 MG Extended Release Oral Tablet	SCD	1544a657-353c-47f8-96ac-a63fa78373f0	1
1988977	24 HR pregabalin 330 MG Extended Release Oral Tablet	SCD	1544a657-353c-47f8-96ac-a63fa78373f0	1
1988980	24 HR pregabalin 82.5 MG Extended Release Oral Tablet	SCD	1544a657-353c-47f8-96ac-a63fa78373f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-464-05	50228046405	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-464-05)	2022-09-14	0000-00-00	No	No	Current
50228-464-30	50228046430	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-464-30)	2022-09-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pregabalin Extended Release	ScieGen Pharmaceuticals, INC.	2022-09-19	HUMAN PRESCRIPTION DRUG LABEL	1