Home NDC 68094-599 Nystatin
Product NDC 68094-599
11-digit product format 680940599
Labeler code 68094
Product ID 68094-599_c5e09aec-bb6a-4a07-b34d-745c94092f2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Precision Dose, Inc.
Application ANDA062512
Marketing category ANDA
Marketing start 2005-12-15
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 500000 [USP'U]/5mL
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A062512-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062512-001 AA
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 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1984-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062512-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA RS 1984-10-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 potassium phosphate, dibasic INACTIVE INGREDIENT CI71S98N1Z NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [PRECISION DOSE, INC.] 2 Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [CARDINAL HEALTH] 1 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [CARDINAL HEALTH] 1
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68094-599-61 68094059961 10 TRAY in 1 CASE (68094-599-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-599-59) 10 tray 2005-12-15 0000-00-00 No No Current 68094-599-62 68094059962 3 TRAY in 1 CASE (68094-599-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-599-59) 3 tray 2005-12-15 0000-00-00 No No Current