Pregabalin

Product NDC: 69539-014
11-digit product format: 695390014
Labeler code: 69539
Product ID: 69539-014_bc069afb-a7ac-4ac9-9b67-2b67f91b20ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA209357
Marketing category: ANDA
Marketing start: 2019-07-19
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 100 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69539-014		D	Discontinued by firm	2026-10-12
excluded package	package	69539-014	69539-014-06	D	Discontinued by firm	2026-10-12
excluded package	package	69539-014	69539-014-90	D	Discontinued by firm	2026-10-12
excluded package	package	69539-014	69539-014-99	D	Discontinued by firm	2026-10-12

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 1 · 4 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	69539-014-06
excluded package	package	69539-014-90
excluded package	package	69539-014-99

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209357-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A209357-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A209357-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A209357-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A209357-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A209357-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A209357-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A209357-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A209357-001	AB
A209357-002	AB
A209357-003	AB
A209357-004	AB
A209357-005	AB
A209357-006	AB
A209357-007	AB
A209357-008	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 9 · 336 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
2026-09-14 22:38:34	2026-08	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209357-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209357-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209357-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209357-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209357-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209357-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-008	AB	1	`6a471c1ec25d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-014	PREGABALIN CAPSULE [MSN LABORATORIES PRIVATE LIMITED]	11	Legacy NDC	20221117_993bedd3-2f7c-40ff-87dc-8a55c6c7a3c7.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	8bb9495e-1354-4a70-baa5-9b80eb3518c8	2024-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4ed3e73c-13e7-4646-874d-276b6c75d2c9	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	d2a98872-1a52-47e1-b4bd-0ff7d6272a92	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-014-06	69539001406	100 BLISTER PACK in 1 CARTON (69539-014-06) > 10 CAPSULE in 1 BLISTER PACK (69539-014-11)	100 blister pack	2019-07-19	0000-00-00	No	No	Current
69539-014-90	69539001490	90 CAPSULE in 1 BOTTLE (69539-014-90)	90 capsule	2019-07-19	0000-00-00	No	No	Current
69539-014-99	69539001499	1000 CAPSULE in 1 BOTTLE (69539-014-99)	1000 capsule	2019-07-19	0000-00-00	No	No	Current