Pregabalin

Product NDC: 70518-3345
Requested package NDC: 70518-3345-2
11-digit product format: 705183345
Labeler code: 70518
Product ID: 70518-3345_4ef355ad-e409-bbdb-e063-6294a90a8166
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA209357
Marketing category: ANDA
Marketing start: 2022-01-27
Substance: PREGABALIN
Active strength: 150 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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209357-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-006	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-007	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209357-008	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	REMEDYREPACK INC.	91edbe87-cd22-43a5-9952-1cd523b13820	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	14f3f9ba-7a4a-45d5-a25e-efe5cdff117d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	44ec2918-4e0c-4e2d-9157-81295a15df57	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	36c3dda1-67fb-4dc5-e063-6294a90a1c3e	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	2e6e6f9c-a14c-2d75-e063-6294a90a827e	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	ba3006b7-991f-4ae0-b908-5910e827e5bf	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357 ndc (package): 70518-3345-2 ndc (product): 70518-3345 ndc11 (package): 70518334502
Pregabalin	PREGABALIN	REMEDYREPACK INC.	5290f7ad-6660-45ff-853d-6dcb947b570d	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	ST. MARY'S MEDICAL PARK PHARMACY	4b94bfc1-88fc-2b5f-e063-6394a90a7077	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	217c9f93-fe89-4684-8553-12ec9acaa507	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	5d33e9c7-6d81-485b-bf4a-9a588eda5208	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	fa24fa02-e27d-476a-b6c4-93650aaaee68	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc89689-bea9-92ec-e053-2995a90a7f21	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	AvPAK	40c0f658-2a0a-034b-e063-6394a90a1097	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Proficient Rx LP	7d25bec8-b503-4f63-8995-372a6df58c72	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	326c643a-23c5-4dab-9266-abc22ca1f874	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Novadoz Pharmaceuticals LLC	193666f7-3c55-43b1-947a-2ffec40c687f	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b1f4b888-ac88-4250-8db1-706e7cc01e93	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b0f34220-0657-4868-ae01-014f9300f622	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Proficient Rx LP	580955ba-86f6-4e86-b0fa-dd44e8828b0e	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	150 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483440	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
f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	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	SPL version
70518-3345-0	Pregabalin	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	7
70518-3345-1	Pregabalin	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	7
70518-3345-2	Pregabalin	30 in 1 BLISTER PACK	CAPSULE	30	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3345	PREGABALIN CAPSULE [REMEDYREPACK INC.]	4	Current NDC, Legacy NDC, 3 package rows	20241004_f30a7a3b-d45e-4e0b-ab1b-1369b2f02320.zip

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
483440	pregabalin 150 MG Oral Capsule	PSN	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	7
483440	pregabalin 150 MG Oral Capsule	SCD	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3345-2	70518334502	30 CAPSULE in 1 BLISTER PACK (70518-3345-2)	30 capsule	2023-03-10	No	No	Current