Ambien

Product NDC: 21695-212
11-digit product format: 216950212
Labeler code: 21695
Product ID: 21695-212_c298d925-bf40-442d-9041-dea5c50fb60b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: NDA019908
Marketing category: NDA
Marketing start: 2009-06-30
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 10 mg/1
Pharmacologic classes: gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75543837-e611-4401-8337-81e7d5cb9b04	Product name	1	20231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4	Product name	3	20201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2	Product name	4	20171109
3970acdc-9e18-4f3d-165e-245802aafc57	Product name	2	20160829
438b1497-0992-6caa-062f-3853a7f9e4b1	Product name	1	20140508
813c8976-a1f1-3a35-1a71-1557bfb59446	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-212-15	2019-09-24	C162847	48780-1	934fe258-477c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992
21695-212-30	2019-09-24	C162847	48780-1	934fe258-477c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992
21695-212-45	2019-09-24	C162847	48780-1	934fe258-477c-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. Ambien® (zolpidem tartrate) tablets CIV Initial U.S. Approval: 1992

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-212-15	Ambien	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
21695-212-30	Ambien	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
21695-212-45	Ambien	45 in 1 BOTTLE	TABLET, FILM COATED	45	1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-212-15	EA - Each	21695-212	7a416f6a-9711-46f8-aab1-395d9a8e787e	1	2012-07-24
21695-212-30	EA - Each	21695-212	0e846d1c-1656-481f-9ffc-71bb3482576e	1	2012-07-24
21695-212-45	EA - Each	21695-212	50c3307c-f2fc-4660-b43e-6da4c8ef14bd	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
zolpidem	ACTIVE MOIETY	7K383OQI23	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-212	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 3 package rows	20100629_9dea009e-d435-4268-ab25-cf48a6c69abb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WY6W63843K	ZOLPIDEM TARTRATE	99294-93-6	ZOLPIDEM TARTRATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854875	AMBIEN 10 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	AMBIEN 5 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854875	zolpidem tartrate 10 MG Oral Tablet [Ambien]	SBD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	zolpidem tartrate 5 MG Oral Tablet [Ambien]	SBD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854875	Ambien 10 MG Oral Tablet	SY	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	Ambien 5 MG Oral Tablet	SY	9dea009e-d435-4268-ab25-cf48a6c69abb	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-212-15	21695021215	15 in 1 BOTTLE	Historical
21695-212-30	21695021230	30 in 1 BOTTLE	Historical
21695-212-45	21695021245	45 in 1 BOTTLE	Historical