PREGABALIN capsules, CV

Product NDC: 50090-5938
11-digit product format: 500905938
Labeler code: 50090
Product ID: 50090-5938_fab0cf97-cc2b-4544-a85e-0728d2b50af2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN capsules, CV
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA212280
Marketing category: ANDA
Marketing start: 2020-01-10
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 75 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-5938		I	Inactivated by FDA		2026-08-17
excluded package	package	50090-5938	50090-5938-0	I	Inactivated by FDA		2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5938-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5938-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5938-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5938-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5938-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5938-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5938-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5938-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5938-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-5938-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-5938-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-5938-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-5938-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-5938-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-5938-0	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5938-0	2024-01-30	C162847	48780-1	1030e364-fe0b-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, CV Initial U.S. Approval:2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5938-0	PREGABALIN capsules, CV	90 in 1 BOTTLE	CAPSULE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5938-0	EA - Each	50090-5938	e398cf7a-4efd-4990-9529-f5ff5ce90551	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5938	PREGABALIN CAPSULES, CV CAPSULE [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 1 package rows	20220317_5d8a6b98-57a6-49c2-a047-72fa142a4416.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

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
483450	pregabalin 75 MG Oral Capsule	PSN	5d8a6b98-57a6-49c2-a047-72fa142a4416	1
483450	pregabalin 75 MG Oral Capsule	SCD	5d8a6b98-57a6-49c2-a047-72fa142a4416	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5938-0	50090593800	90 CAPSULE in 1 BOTTLE (50090-5938-0)	90 capsule	2022-03-10	0000-00-00	No	No	Current