PREGABALIN capsules, CV

Product NDC: 69097-677
Requested package NDC: 69097-677-21
11-digit product format: 690970677
Labeler code: 69097
Product ID: 69097-677_22a469ee-1346-4abb-84f1-4c2caf26437b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN capsules, CV
Dosage form: CAPSULE
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA212280
Marketing category: ANDA
Marketing start: 2020-01-10
Substance: PREGABALIN
Active strength: 25 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69097-677	69097-677-21	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A212280-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	2020-01-10
A212280-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	2020-01-10
A212280-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	2020-01-10
A212280-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	2020-01-10
A212280-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	2020-01-10
A212280-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	2020-01-10
A212280-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	2020-01-10
A212280-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	2020-01-10

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 8 · 304 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212280-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212280-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212280-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212280-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212280-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212280-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212280-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212280-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212280-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212280-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212280-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212280-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212280-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212280-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212280-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212280-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212280-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212280-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212280-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212280-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212280-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212280-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212280-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212280-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212280-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212280-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-01-10	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 184 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A212280-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212280-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212280-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212280-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212280-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212280-006	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212280-007	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212280-008	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-007	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212280-008	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212280-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212280-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212280-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212280-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212280-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212280-006	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212280-007	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212280-008	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212280-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212280-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212280-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212280-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212280-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212280-006	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212280-007	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212280-008	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212280-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212280-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212280-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212280-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212280-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212280-006	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212280-007	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212280-008	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: PREGABALIN capsules, CV
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	25 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483438	Internal RxNorm lookup
483440	Internal RxNorm lookup
483442	Internal RxNorm lookup
483444	Internal RxNorm lookup
483446	Internal RxNorm lookup
483448	Internal RxNorm lookup
483450	Internal RxNorm lookup
577127	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
7d93359c-1849-430d-a922-21d42932d0f3	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
69097-677-02	PREGABALIN capsules, CV	30 in 1 BOTTLE	CAPSULE	30	9
69097-677-05	PREGABALIN capsules, CV	90 in 1 BOTTLE	CAPSULE	90	9
69097-677-12	PREGABALIN capsules, CV	500 in 1 BOTTLE	CAPSULE	500	9
69097-677-19	PREGABALIN capsules, CV	10 in 1 BLISTER PACK	CAPSULE	10	9
69097-677-21	PREGABALIN capsules, CV	100 in 1 CARTON	CAPSULE	100	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-677	PREGABALIN CAPSULES, CV CAPSULE [CIPLA USA INC.]	7	Current NDC, Legacy NDC, 5 package rows	20211123_7d93359c-1849-430d-a922-21d42932d0f3.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 capsules, CV	PREGABALIN CAPSULES, CV	Cipla USA Inc.	7d93359c-1849-430d-a922-21d42932d0f3	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212280 application number: ANDA212280 ndc (package): 69097-677-21 ndc (product): 69097-677 ndc11 (package): 69097067721

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
483438	pregabalin 100 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
483440	pregabalin 150 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
483446	pregabalin 200 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
577127	pregabalin 225 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
483442	pregabalin 25 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
483444	pregabalin 300 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
483448	pregabalin 50 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
483450	pregabalin 75 MG Oral Capsule	PSN	7d93359c-1849-430d-a922-21d42932d0f3	9
483438	pregabalin 100 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9
483440	pregabalin 150 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9
483446	pregabalin 200 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9
577127	pregabalin 225 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9
483442	pregabalin 25 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9
483444	pregabalin 300 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9
483448	pregabalin 50 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9
483450	pregabalin 75 MG Oral Capsule	SCD	7d93359c-1849-430d-a922-21d42932d0f3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-677-21	69097067721	100 BLISTER PACK in 1 CARTON (69097-677-21) > 10 CAPSULE in 1 BLISTER PACK (69097-677-19)	100 blister pack	2020-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREGABALIN capsules, CV	Cipla USA Inc. \| CIPLA LIMITED KURKUMBH	2025-12-22	HUMAN PRESCRIPTION DRUG LABEL	9