NITROFURANTOIN

Product NDC: 72189-179
Requested package NDC: 72189-179-10
11-digit product format: 721890179
Labeler code: 72189
Product ID: 72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NITROFURANTOIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Directrx
Application: ANDA077066
Marketing category: ANDA
Marketing start: 2022-01-18
Substance: NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength: 25; 75 mg/1; mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 1 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-179	72189-179-10	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2005-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077066-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077066-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077066-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	ae892973-9ef4-4cf0-baf3-fbe158697bac	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	St. Mary's Medical Park Pharmacy	87210c87-b7db-0f65-e053-2a91aa0a4393	2026-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	0631d961-ef23-8f2a-e063-6294a90aa0a8	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	7767697f-4dd0-477d-b5cc-e1ed5689f097	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	643cdcff-8599-4326-b3ca-d9fd270e0fc2	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	04b4189e-9b21-78ed-e063-6394a90ab8e0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	fbc05ccb-782b-55f6-e053-6394a90a7fd6	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b644426c-c8ba-4fe0-80c7-d9b2dde37395	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
NITROFURANTOIN	NITROFURANTOIN	Directrx	d4385368-46d6-8397-e053-2a95a90a8d68	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (package): 72189-179-10 ndc (product): 72189-179 ndc11 (package): 72189017910
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	68a651f9-1aef-792e-e053-2991aa0a3cbb	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	6bccbaab-151b-4a04-e053-2991aa0ae105	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Sandoz Inc	7ba9a729-a73a-4a13-a336-0284cc8a67e1	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	05f4b126-0fb9-5ee9-c89c-f229e60f84e3	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Asclemed USA, Inc.	1ab658f0-021a-46a1-bff3-d3334c23442d	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Proficient Rx LP	d802d734-dc8f-4f3c-bce6-aaccc4614c89	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	25 mg/1
NITROFURANTOIN MONOHYDRATE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
927AH8112L	Internal UNII lookup
E1QI2CQQ1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1648755	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d4385368-46d6-8397-e053-2a95a90a8d68	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cf	Product name	6	20251106
f6207266-e92b-4b5b-a91b-4af4215c9542	Product name	6	20240813
e31776f7-6119-9577-e170-5b569993276e	Product name	5	20240320

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72189-179-10	NITROFURANTOIN	10 in 1 BOTTLE	CAPSULE	10	4
72189-179-14	NITROFURANTOIN	14 in 1 BOTTLE	CAPSULE	14	4
72189-179-20	NITROFURANTOIN	20 in 1 BOTTLE	CAPSULE	20	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-179-10	EA - Each	72189-179	db628722-3061-41a2-ad38-95e6f8bc666a	1	2022-11-07
72189-179-14	EA - Each	72189-179	56ee474b-7ae2-40dc-804a-a7ec4bcedc95	1	2022-02-07
72189-179-20	EA - Each	72189-179	78508fe2-d9c8-40f0-bbb2-b05bdbd4d748	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-179	NITROFURANTOIN CAPSULE [DIRECTRX]	4	Current NDC, Legacy NDC, 3 package rows	20250119_d4385368-46d6-8397-e053-2a95a90a8d68.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN
E1QI2CQQ1I	NITROFURANTOIN MONOHYDRATE	17140-81-7	NITROFURANTOIN MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648755	nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule	PSN	d4385368-46d6-8397-e053-2a95a90a8d68	4
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	d4385368-46d6-8397-e053-2a95a90a8d68	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-179-10	72189017910	10 CAPSULE in 1 BOTTLE (72189-179-10)	10 capsule	2022-01-18	0000-00-00	No	No	Current