Pregabalin

Product NDC: 71610-315
Requested package NDC: 71610-315-53
11-digit product format: 716100315
Labeler code: 71610
Product ID: 71610-315_d3a04565-4603-4165-b954-cc704e9f27b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA211384
Marketing category: ANDA
Marketing start: 2019-07-19
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-315	71610-315-53	D	Discontinued by firm		2026-10-05

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-315	71610-315-53	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-315	71610-315-53	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	71610-315	71610-315-53	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
A211384-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A211384-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A211384-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A211384-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A211384-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A211384-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A211384-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A211384-008	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
A211384-001	AB
A211384-002	AB
A211384-003	AB
A211384-004	AB
A211384-005	AB
A211384-006	AB
A211384-007	AB
A211384-008	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	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-008	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	A211384-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211384-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211384-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211384-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-008	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71610-315-30	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-30	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-46	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-46	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-53	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-53	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-70	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-70	2024-03-04	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-30	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-30	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-46	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-46	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-53	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-53	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-70	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-70	2023-01-30	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-315-30	Pregabalin	30 in 1 BOTTLE	CAPSULE	30	11
71610-315-46	Pregabalin	56 in 1 BOTTLE	CAPSULE	56	11
71610-315-53	Pregabalin	60 in 1 BOTTLE	CAPSULE	60	11
71610-315-70	Pregabalin	120 in 1 BOTTLE	CAPSULE	120	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-315-30	EA - Each	71610-315	47c1bd94-0fcc-420f-ba3b-1b4647bbc692	1	2019-10-07
71610-315-46	EA - Each	71610-315	e7ab0ab8-daed-4719-bd9c-231055d48051	1	2019-10-07
71610-315-53	EA - Each	71610-315	6eba7028-209f-47d3-875e-394d9ee19713	1	2019-10-07
71610-315-70	EA - Each	71610-315	5b3f846e-3c6a-4e58-a147-d0c16768a479	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-315	PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	8	Legacy NDC, 4 package rows	20240305_bf710bcf-75ed-4184-b9c3-81cd05a780a4.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 · 4 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	bf710bcf-75ed-4184-b9c3-81cd05a780a4	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384 ndc (package): 71610-315-53 ndc (product): 71610-315 ndc11 (package): 71610031553
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ef7c2e2c-c314-4bfd-a9fa-39f0b0884d34	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384
Pregabalin	PREGABALIN	Cipla USA, Inc.	17a8087c-579f-42de-ae92-006ea64def2a	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384
Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	3fdc6e94-2504-416c-81dd-2db9bc194ebb	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384

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	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483440	pregabalin 150 MG Oral Capsule	PSN	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483446	pregabalin 200 MG Oral Capsule	PSN	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
577127	pregabalin 225 MG Oral Capsule	PSN	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483442	pregabalin 25 MG Oral Capsule	PSN	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483444	pregabalin 300 MG Oral Capsule	PSN	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483448	pregabalin 50 MG Oral Capsule	PSN	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483450	pregabalin 75 MG Oral Capsule	PSN	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483438	pregabalin 100 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483440	pregabalin 150 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483446	pregabalin 200 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
577127	pregabalin 225 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483442	pregabalin 25 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483444	pregabalin 300 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483448	pregabalin 50 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11
483450	pregabalin 75 MG Oral Capsule	SCD	bf710bcf-75ed-4184-b9c3-81cd05a780a4	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-315-53	71610031553	60 CAPSULE in 1 BOTTLE (71610-315-53)	60 capsule	2019-08-12	0000-00-00	No	No	Current