Nifedipine

Product NDC
62175-261
11-digit product format
621750261
Labeler code
62175
Product ID
62175-261_2b91b384-4c20-4162-a717-9dc53ea834cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA077127
Marketing category
ANDA
Marketing start
2005-11-21
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077127-001NIFEDIPINENIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21
A077127-002NIFEDIPINENIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21
A077127-003NIFEDIPINENIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077127-001AB2
A077127-002AB2
A077127-003AB2

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077127-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077127-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077127-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077127-001AB218072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I9ZF7L6G2LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1812011Internal RxNorm lookup
1812013Internal RxNorm lookup
1812015Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
331db003-cc8e-4509-9415-20e48c5cc5b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-261-37Nifedipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10028
62175-261-46Nifedipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9028
62175-261-55Nifedipine300 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-261-37EA - Each62175-261e1678429-2cf4-49d5-84b6-8d09331c02ef12012-07-24
62175-261-43EA - Each62175-261a69cb75c-375b-4617-92d7-5866f00154cc12012-07-24
62175-261-46EA - Each62175-261a48f7487-24dc-4136-a335-ffa16b2a3f9c12012-07-24
62175-261-55EA - Each62175-261bce8163c-0c9c-4be6-82d4-299f0d57a1d012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]15
NifedipineACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
NifedipineACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Cellulose AcetateINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
HypromellosesINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Magnesium StearateINACTIVE INGREDIENT70097M6I30NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
PovidoneINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
TriacetinINACTIVE INGREDIENTXHX3C3X673NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]9
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-261NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [LANNETT COMPANY, INC.]28Current NDC, Legacy NDC, 3 package rows20230629_331db003-cc8e-4509-9415-20e48c5cc5b2.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nifedipine ERNIFEDIPINEAvPAKd1a78ff2-7672-3e69-00ef-63d203c804842026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEChartwell RX, LLC0a8e3090-7733-4914-bacb-01bbdc8deb302025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEPD-Rx Pharmaceuticals, Inc.86c1bdae-c749-4ec3-90f6-7ebe8e76c4612025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINECardinal Health 107, LLC593d8ca3-c303-4512-96a6-d4860e02cd832025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEAmerican Health Packagingb11026f8-dea0-49ac-8725-0ef7dc27923f2025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEPD-Rx Pharmaceuticals, Inc.75003769-7800-4bc7-b709-35b4caec2c2f2025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINELannett Company, Inc.331db003-cc8e-4509-9415-20e48c5cc5b22023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
ndc (product): 62175-261
NifedipineNIFEDIPINEA-S Medication Solutionsec13ec71-626f-4664-b264-f67ba72071ae2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEProficient Rx LP4b6418a8-600f-470e-adf1-56207bb25c382019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN331db003-cc8e-4509-9415-20e48c5cc5b228
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN331db003-cc8e-4509-9415-20e48c5cc5b228
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN331db003-cc8e-4509-9415-20e48c5cc5b228
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD331db003-cc8e-4509-9415-20e48c5cc5b228
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD331db003-cc8e-4509-9415-20e48c5cc5b228
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD331db003-cc8e-4509-9415-20e48c5cc5b228
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY331db003-cc8e-4509-9415-20e48c5cc5b228
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY331db003-cc8e-4509-9415-20e48c5cc5b228
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY331db003-cc8e-4509-9415-20e48c5cc5b228
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNd1a78ff2-7672-3e69-00ef-63d203c8048416
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNd1a78ff2-7672-3e69-00ef-63d203c8048416
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNd1a78ff2-7672-3e69-00ef-63d203c8048416
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDd1a78ff2-7672-3e69-00ef-63d203c8048416
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDd1a78ff2-7672-3e69-00ef-63d203c8048416
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDd1a78ff2-7672-3e69-00ef-63d203c8048416
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYd1a78ff2-7672-3e69-00ef-63d203c8048416
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYd1a78ff2-7672-3e69-00ef-63d203c8048416
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYd1a78ff2-7672-3e69-00ef-63d203c8048416
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN7744c47b-e9bb-4ee3-a1a8-d0180e7c0b3b1
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN7744c47b-e9bb-4ee3-a1a8-d0180e7c0b3b1
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN4bb9f3b7-2cc0-487d-9afa-027ddf7d7c161
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN75003769-7800-4bc7-b709-35b4caec2c2f1
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD7744c47b-e9bb-4ee3-a1a8-d0180e7c0b3b1
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD7744c47b-e9bb-4ee3-a1a8-d0180e7c0b3b1
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD75003769-7800-4bc7-b709-35b4caec2c2f1
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD4bb9f3b7-2cc0-487d-9afa-027ddf7d7c161
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY7744c47b-e9bb-4ee3-a1a8-d0180e7c0b3b1
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY7744c47b-e9bb-4ee3-a1a8-d0180e7c0b3b1
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY75003769-7800-4bc7-b709-35b4caec2c2f1
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY4bb9f3b7-2cc0-487d-9afa-027ddf7d7c161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-261-3762175026137100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-261-37) 2005-11-210000-00-00NoNoCurrent
62175-261-43621750261431000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-261-43) 2005-11-210000-00-00NoNoCurrent
62175-261-466217502614690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-261-46) 2005-11-210000-00-00NoNoCurrent
62175-261-5562175026155300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-261-55) 2005-11-210000-00-00NoNoCurrent