Home NDC 51672-1289 Nystatin
Product NDC 51672-1289
11-digit product format 516721289
Labeler code 51672
Product ID 51672-1289_3908cf94-b2b6-30a4-e063-6394a90add43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA064022
Marketing category ANDA
Marketing start 1993-01-28
Substance NYSTATIN
Active strength 100000 [USP'U]/g
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A064022-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A064022-001 AT
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064022-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT RS 1993-01-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 543546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1289-1 Nystatin 15 g in 1 TUBE CREAM 15 6 51672-1289-1 Nystatin 1 in 1 CARTON CREAM 1 6 51672-1289-2 Nystatin 1 in 1 CARTON CREAM 1 6 51672-1289-2 Nystatin 30 g in 1 TUBE CREAM 30 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 algeldrate INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 ceteareth-15 INACTIVE INGREDIENT 867H4YOZ8Z NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 NYSTATIN ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 NYSTATIN ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 ALGELDRATE INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ALGELDRATE INACTIVE INGREDIENT 03J11K103C NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 CETEARETH-12 INACTIVE INGREDIENT 7V4MR24V5P NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 CETEARETH-15 INACTIVE INGREDIENT 867H4YOZ8Z NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN CREAM [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1289 NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 4 package rows 20230126_4d845b3f-ca26-4c47-b424-b6d783cc10e5.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 · 5 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 543546 nystatin 100,000 UNT/GM Topical Cream PSN 4d845b3f-ca26-4c47-b424-b6d783cc10e5 6 543546 nystatin 100000 UNT/ML Topical Cream SCD 4d845b3f-ca26-4c47-b424-b6d783cc10e5 6 543546 nystatin 100,000 UNT/GM Topical Cream SY 4d845b3f-ca26-4c47-b424-b6d783cc10e5 6 543546 nystatin 100,000 UNT/GM Topical Cream PSN 57825c04-dcb5-b76d-e053-2991aa0a4c1d 4 543546 nystatin 100,000 UNT/GM Topical Cream PSN cd387929-5b72-e3c0-e053-2a95a90adb22 4 543546 nystatin 100000 UNT/ML Topical Cream SCD 57825c04-dcb5-b76d-e053-2991aa0a4c1d 4 543546 nystatin 100000 UNT/ML Topical Cream SCD cd387929-5b72-e3c0-e053-2a95a90adb22 4 543546 nystatin 100,000 UNT/GM Topical Cream SY 57825c04-dcb5-b76d-e053-2991aa0a4c1d 4 543546 nystatin 100,000 UNT/GM Topical Cream SY cd387929-5b72-e3c0-e053-2a95a90adb22 4 543546 nystatin 100,000 UNT/GM Topical Cream PSN 5ef15e1c-66dc-4858-8552-d83e42c3883e 3 543546 nystatin 100,000 UNT/GM Topical Cream PSN cf6b7c68-7769-1808-e053-2995a90aa426 3 543546 nystatin 100000 UNT/ML Topical Cream SCD 5ef15e1c-66dc-4858-8552-d83e42c3883e 3 543546 nystatin 100000 UNT/ML Topical Cream SCD cf6b7c68-7769-1808-e053-2995a90aa426 3 543546 nystatin 100,000 UNT/GM Topical Cream SY cf6b7c68-7769-1808-e053-2995a90aa426 3 543546 nystatin 100,000 UNT/GM Topical Cream SY 5ef15e1c-66dc-4858-8552-d83e42c3883e 3 543546 nystatin 100,000 UNT/GM Topical Cream PSN bdb80797-20c8-4fbc-8ef8-b85d6aebdce5 1 543546 nystatin 100000 UNT/ML Topical Cream SCD bdb80797-20c8-4fbc-8ef8-b85d6aebdce5 1 543546 nystatin 100,000 UNT/GM Topical Cream SY bdb80797-20c8-4fbc-8ef8-b85d6aebdce5 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1289-1 51672128901 1 TUBE in 1 CARTON (51672-1289-1) / 15 g in 1 TUBE 1 tube 1993-01-28 0000-00-00 No No Current 51672-1289-2 51672128902 1 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE 1 tube 1993-01-28 0000-00-00 No No Current