Pregabalin

Product NDC: 72888-051
11-digit product format: 728880051
Labeler code: 72888
Product ID: 72888-051_49fe33c0-b2ae-e0c1-e063-6294a90a36a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Advagen Pharma Ltd.
Application: ANDA215249
Marketing category: ANDA
Marketing start: 2022-03-22
Substance: PREGABALIN
Active strength: 330 mg/1
DEA schedule: CV
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215249-001	PREGABALIN	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22
A215249-002	PREGABALIN	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22
A215249-003	PREGABALIN	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215249-001	AB
A215249-002	AB
A215249-003	AB

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 · 90 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	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-002	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-003	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215249-001	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 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	A215249-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215249-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215249-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215249-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215249-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215249-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215249-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215249-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215249-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215249-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215249-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215249-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215249-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215249-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215249-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215249-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215249-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

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
2ffee7e7-bfa0-4933-9baf-7df55080816e	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
004d1029-ec13-fc89-74f4-3907cf5b6602	Product name	2	20140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72888-051-30	Pregabalin	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-051-30	EA - Each	72888-051	ff8505c3-05ab-49a4-bb16-933ed676369f	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-051	PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE [ADVAGEN PHARMA LTD.]	2	Current NDC, Legacy NDC, 1 package rows	20230504_2ffee7e7-bfa0-4933-9baf-7df55080816e.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	PREGABALIN	Advagen Pharma Ltd.	2ffee7e7-bfa0-4933-9baf-7df55080816e	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215249 application number: ANDA215249 ndc (product): 72888-051

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	2ffee7e7-bfa0-4933-9baf-7df55080816e	4
1988977	pregabalin 330 MG 24HR Extended Release Oral Tablet	PSN	2ffee7e7-bfa0-4933-9baf-7df55080816e	4
1988980	pregabalin 82.5 MG 24HR Extended Release Oral Tablet	PSN	2ffee7e7-bfa0-4933-9baf-7df55080816e	4
1988974	24 HR pregabalin 165 MG Extended Release Oral Tablet	SCD	2ffee7e7-bfa0-4933-9baf-7df55080816e	4
1988977	24 HR pregabalin 330 MG Extended Release Oral Tablet	SCD	2ffee7e7-bfa0-4933-9baf-7df55080816e	4
1988980	24 HR pregabalin 82.5 MG Extended Release Oral Tablet	SCD	2ffee7e7-bfa0-4933-9baf-7df55080816e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72888-051-30	72888005130	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72888-051-30)	2022-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pregabalin	Advagen Pharma Ltd. \| Rubicon Research Limited	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	4