dicyclomine hydrochloride

Product NDC: 68151-1161
11-digit product format: 681511161
Labeler code: 68151
Product ID: 68151-1161_04243592-1a86-4b99-ac93-eb16974bc7d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dicyclomine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA040169
Marketing category: ANDA
Marketing start: 2005-06-23
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/5mL
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-1161		I	Inactivated by FDA		2026-08-03
excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA		2026-08-03

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 · 30 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	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	68151-1161		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-1161	68151-1161-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	68151-1161		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-1161	68151-1161-1	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
A040169-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040169-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040169-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040169-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040169-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040169-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040169-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040169-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040169-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040169-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040169-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040169-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040169-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040169-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040169-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040169-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040169-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040169-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040169-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040169-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040169-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040169-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040169-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040169-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040169-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040169-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040169-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040169-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040169-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040169-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040169-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040169-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040169-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040169-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040169-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040169-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040169-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040169-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040169-001	AA	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Par Health USA, LLC	bb099db9-f635-4a64-8892-6236971dec45	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040169 application number: ANDA040169

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f755a917-03bc-45af-a1e3-50286868bfdb	Product name	9	20250303
f27796e1-d653-495b-932a-f51768e9be8a	Product name	2	20211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-1161-1	2020-01-31	C162847	48780-1	9d75b9d0-1858-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine hydrochloride oral solution Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-1161-1	dicyclomine hydrochloride	1 mL in 1 SYRINGE, PLASTIC	SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-1161	DICYCLOMINE HYDROCHLORIDE SOLUTION [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20171229_da753e89-d5ec-4183-920b-aa1c4e8c2197.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CQ903KQA31	DICYCLOMINE HYDROCHLORIDE	67-92-5	DICYCLOMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991082	dicyclomine HCl 10 MG in 5 mL Oral Solution	PSN	da753e89-d5ec-4183-920b-aa1c4e8c2197	2
991082	dicyclomine hydrochloride 2 MG/ML Oral Solution	SCD	da753e89-d5ec-4183-920b-aa1c4e8c2197	2
991082	dicyclomine HCl 10 MG per 5 ML Oral Solution	SY	da753e89-d5ec-4183-920b-aa1c4e8c2197	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68151-1161-1	68151116101	1 mL in 1 SYRINGE, PLASTIC	1 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
dicyclomine hydrochloride	Carilion Materials Management	2017-12-28	HUMAN PRESCRIPTION DRUG LABEL	2