Home NDC 73254-310-01 ExEm Foam
Product NDC 73254-310
Requested package NDC 73254-310-01
11-digit product format 732540310
Labeler code 73254
Product ID 73254-310_09acadb7-c0a2-d753-e063-6294a90af9a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Air Polymer-Type A Intrauterine Foam
Dosage form KIT
Route INTRAUTERINE
Labeler GISKIT PHARMA B.V.
Application NDA212279
Marketing category NDA
Marketing start 2020-10-16
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 43 .
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 N212279-001 EXEM FOAM KIT AIR POLYMER-TYPE A 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 N212279-001 9849199 2036-02-11 Drug product 2019-12-10
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.
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 2026-09-14 22:38:34 2026-08 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD 2019-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212279-001 EXEM FOAM KIT 10ML FOAM / INTRAUTERINE RLD, RS 2019-11-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 117 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 9259494 2035-05-04 U-2663 Drug product 2019-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212279-001 9849199 2036-02-11 Drug product 2019-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212279-001 9034300 2030-10-15 U-2663 Drug product 2019-12-10 301d65b070ca…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ExEm Foam
Listing expiration 2026-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73254-310-01 ExEm Foam 1 in 1 CARTON KIT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73254-310 EXEM FOAM (AIR POLYMER-TYPE A INTRAUTERINE FOAM) KIT [GISKIT PHARMA B.V.] 7 Current NDC, Legacy NDC, 1 package rows 20231109_b8cb3e4d-ed22-4e88-abca-508c794b4b91.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73254-310-01 73254031001 1 KIT in 1 CARTON (73254-310-01) * 5 mL in 1 SYRINGE, PLASTIC * 5 mL in 1 SYRINGE, PLASTIC 1 kit 2020-10-16 0000-00-00 No No Current